NORMATEC Go Massage with Air Instruction Manual

NORMATEC Go Massage with Air

| TO REDUCE RISKS OF ELECTRIC SHOCK, FIRE, AND PERSONAL INJURY, OR PROPERTY DAMAGE, THIS DEVICE MUST BE USED IN ACCORDANCE WITH THE FOLLOWING WARNINGS, CAUTIONS, AND SAFETY INSTRUCTIONS
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IMPORTANT SAFETY INSTRUCTIONS

Read the entire instruction manual before using the Normatec Go System

WARNING
No modification of this equipment is allowed.

If you experience severe pain, any unusual symptoms, or want to remove the wrap in an emergency during use:

• Stopthe control unit by pressing the power button.
• Remove the wraps from your limbs.
• Promptly consult your licensed healthcare practitioner, as required.

CAUTION

• Do not attempt totake apart the system. The system has no user serviceable parts. When service or repairs are required, please contact customer service at +1.949.565.4994.
• Do not remove or attempt to disassemble the control unit.
• To avoid risk of electric shock, do not use the system near water, such as near a bathtub, kitchen sink, laundry tub, or swimming pool.
• To avoid damage and risk of electric shock, never spill liquid of any kind on the system.
• Do not place the system, charger, or any accessories where they could be damaged, present a fall hazard, or become an obstruction to others.
• If the charger is damaged, the device is dropped or damaged, liquid is spilled on the system, or the system does not operate normally when the operating instructions are followed, turn the system off by pushing the control unit’s power button and unplug the system from the wall outlet. Contact customer service at +1.949.565.4994 for assistance.
• Do not puncture or otherwise damage the wrap as this may cause the system to operate incorrectly.
• To avoid risk of strangulation, do not leave a baby or child unattended with the system.
• Choking hazard, small parts.Keep away from small children.
• Do not leave the system, charger, or any accessories where they could be damaged by children, pets, pests, orliquids. If you suspect your control unit is damaged, contact customer service at +1.949.565.4994 for assistance.
• Do not allow lint or dust to accumulate on the control unit or the wrap. If lint or dust accumulates, wipe down the system with a dry cloth before use.
• TheIP22 classification means the control unit is protected against the ingress of vertically dripping water andthe hazardous parts are protected against access to objects equal to or larger than 12.5 mm (1/2”).
• The expected service life of the system and the integrated battery is 3 years.
• The wraps are designed to be used by only one person at a time.
• Product is to be used by adults only in good health.
• Consult your physician before using this product if you are under the care of a physician or have a contraindication requiring the use of any medical device.
• Consult your physician before using this product if you are experiencing inflammation, an infection, pain of unknown origin, bleeding (internal or external) at or near the site of application, or if you have a wound at or near the site of application.
• Consult your physician before using this product on sensitive skin.
• Consult your physician before using this product if you have any of the following conditions:
  • Acute pulmonary edema
  • Acute thrombophlebitis
  • Acute congestive cardiac failure
  • Acute infections
  • Deep vein thrombosis (DVT)
  • Episodes of pulmonary embolism
  • Wounds, lesions, or tumors at or near the site of application
  • Whereincreased venous and lymphatic return is undesirable
  • Bone fractures or dislocations at or near the site of application
• Use by unconscious or incapacitated persons may be dangerous without supervision.
• Make sure the power inlet on the control unit is easily accessible at all times in orderto disconnect power if required.

The Normatec Go control unit contains a Li-ion battery. The battery must be complied with safely at an appropriate e-waste disposal or recycling facility.

SAVE THESE INSTRUCTIONS

LABELS

Thefollowing labels and symbols appear onthe control unit, fabric tag, and/or packaging.

Symbol

| Description| Location
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| Degree of protection against ingress of water| On fabric tag
| Read instructions before use| On fabric tag
| Direct current| On charger
| Level of protection type BF equipment| On fabric tag
| Double insulation| On charger
| Alternating current| In manual
| Manufacturer’s name and address| On fabric tag
| Separate collection for waste electrical and electronic equipment.| On fabric tag
| Serial number of the console| On base of control unit
| Fragile, handle with care| On package
| Keep dry| On package and fabric tag
| This side up| On package
| Keep away from sunlight| On package
| Transportation and storage humidity limitation| On package
| Transportation and storage atmospheric pressure limitation| On package
| Transportation and storage temperature limitation| On package
| Place in and out of standby mode| On side of control unit
| Do not wash| On fabric tag
| Do not dry clean| On fabric tag
| Do not tumble dry| On fabric tag
| Do not bleach| On fabric tag
| Do not iron| On fabric tag
| EU RF transmitter symbol| In manual
| The Bluetooth figure mark| On packaging
| Warning symbol to identify a hazard that may lead to death or serious injury| In manual
| Caution symbol to indicate the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical control unit itself| In manual
| Tip to provide guidance to make use easier. Risk to user is considered negligible| In manual
| Catalog/Model Number| On fabric tag
| EC Representative| On fabric tag
| European Conformity Notified Body| On device
| Medical Device Symbol| On fabric tag
| Australia RCM| On fabric tag
| Made in China| On fabric tag
| UK Mark| On fabric tag
| North American NRTL Mark| On fabric tag
| Recycle Lithium-Ion| On fabric tag
| Taiwan battery recycle| On fabric tag
| Taiwan RoHS| On fabric tag
| Taiwan Radio Certification| On fabric tag
| Recycle Lithium-Ion| On control unit

INDICATIONS FOR USE

The Normatec Go is an air compression massager indicated to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas.

RISKS AND BENEFITS OF THE NORMATEC GO SYSTEM

The risks and benefits of using the Normatec Go System are similar to having a massage. If the Normatec Go massage feels uncomfortable, you can reduce the intensity or stop the session. Benefits include the temporary relief of minor muscle aches and pains, and increased circulation in the area being treated. Please call customer service at +1.949.565.4994 if you have any questions.

ILLUSTRATIONS

Normatec Go Control Unit (single person use only)

1. Power Button
2. 2 USB-C Charging Port
3. Pressure Level Button
4. Time Adjustment Button
5. Start / Stop Button
6. Display Screen
7. Battery Status Indicators

Normatec Go Charger and USB Cable

1. USB Charger

2. USB Cable
   

OPERATING INSTRUCTIONS

WARNING! BEFORE OPERATING THIS SYSTEM:
Read all warnings at the beginning of this manual. If you do not understand these operating instructions, contact Hyperice at +1.949.565.4994.

CHARGING THE SYSTEM

• Step 1: Plugthe USB cable into the control unit • Step 2: Plug the USB cable into the charger
• Step 3: Plug the USB chargerinto the wall outlet
• While the control unit is charging the battery status indicators will cycle from left to right. When all 5 battery status indicators are on ON, this means that the system is fully charged.
  Thecontrol unit will NOT power on and cannot be operated while the USB cable is connected.

SET UP THE SYSTEM

• Step 1: Securethe wraptightly around your calf. Affix the two sides of the hook and loop material together for a snug but comfortable fit.
• Step 2: Press the power button on the Normatec Go control unit firmly for one second to turn on the system. While the control unit is on, the battery LEDs and display screen will light up.

ADJUST THE PRESSURE LEVEL
Adjust the pressure level of the session by pressing the pressure level adjustment button on the top left of the control panel. Pressure level 1 is the gentlest setting. The massage becomes more intense as the pressure level is increased. Level can be adjusted while the session is running.

ADJUST THE SESSION TIME
Adjust the session time by pressing the time adjustment button. The session time can be set to 15, 30, 45 and 60 minutes. Time can be adjusted while the session is running. Press the time adjustment buttons to cycle through the session time options to add or subtract time from the session.

START THE SESSION

To start the session, press the start/Stop button.

PATENTED NORMATEC PULSE MASSAGE PATTERN
The patented Normatec Go massage pattern will begin by compressing your upper ankle. Similar to the kneading and stroking performed during a massage, each zone of the wrap will first compress in a pulsing manner and then hold as the compression pattern works its way up yourlower limb. When the top zone completes its massage, there will be a briefrest period and then the cycle will begin again. This will repeat untilthe session time runs out.

Thezones on the wrap are numbered in ascending order from distal zone to proximal zone. Zone 1 corresponds tothe upper ankle, Zone 2 corresponds to the lower calf, and Zone 3 is the upper calf.

STOP OR PAUSE THE SESSION
To stop the session at any time, press the start/stop button. This will pause the session. To restart your paused session, press the start/stop button again. If you are done using the system, remove the wraps from your limbs, and turn off the control unit by pressing the power button.

FINISH THE SESSION
The session will continue massaging until time runs out and the display reads “Finishing Cycle”. The system will continue untilthe current cycle is finished. When the session is complete, remove the wraps from your limbs, and turn off the control unit by pressing the power button.

TURN OFF THE CONTROL UNIT
Toturn off the system, press the power button and confirm that the Battery Status Indicators and Display are off.

CONNECTING TO THE HYPERICE APP
Download the Hyperice Appfrom theApp Store or the GooglePlay Store. To connect your system to the Hyperice App via Bluetooth open theApp, make surethe control unit is turned on, Bluetooth is turned on in your phone, and your control unit is within close proximity. Select a routine within the Hyperice App and if prompted tap “Scan for Devices.” Select your system when it pops up on the screen. HyperSmart™ will automatically start your session, and adjust pressure along the way.

CYBER SECURITY
It is recommended to configure the Hyperice App for automatic updates to ensure cyber security. It is also recommended to keep your Operating System upto date and to configure your Operating Systemfor automatic updates.

CLEANING THE SYSTEM

Toclean the control unit:

• Wipe down the system with a damp, clean cloth.
• Dry thoroughly with a clean cloth.

Cleaningthe single-person use wrap:

• Wipe down the wrap inside and out with a damp, clean cloth.
• Dry thoroughly with a clean cloth.
• Do not machine wash or dry.
• Do not dry clean

MAINTAINING THE SYSTEM

Thesystem requires no routine maintenance or service except for the care in this section.

STORING THE SYSTEM
Storethe system in a clean, dry location

REPLACEMENT PARTS

Please call customer service at +1.949.565.4994 or visit our website at hyperice.com for information regarding available replacement parts and accessories.

TECHNICAL INFORMATION

Do not attempt to take a part the system. Thesystem has no user-serviceable parts.There are no user-replaceable fuses.

BLUETOOTH® WIRELESS TECHNOLOGY

The Bluetooth® word mark and logos are owned by Bluetooth® SIG, Inc., and any use of such marks by Hyperice is under license. In the unlikely event of loss of a stable Bluetooth connection, the system will attempt to re-establish its connection automatically. The Normatec Go control unit is completely autonomous, and will continue operating normally, even during a loss of connectivity. If this control unit does cause interference, which can be determined by turning the control unit off and on, the user is encouraged to try to correct the interference by reorienting or relocating the control unit, increasing the separation between equipment and the control unit, or connecting the control unit to a different outlet on a circuit if it is plugged in.

The Normatec Go control unit uses Bluetooth 5.0 wireless technology with the following radio specifications:

 |

FCC ID: 2AY3Y-NTG
IC: 23655-NTG

|

FCC ID: 2AY3Y-NTGA
IC:23655-NTGA

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Frequency|

2402 to 2480 MHz, 433.92MHz

Modulations|

GFSK

Transmit Power|

see test report

Receiver Sensitivity|

-96 dBm (BLE mode), -118 dBM (ULP)

Security|

AES HW

FCC ID: 2AY3Y-NTG IC:23655-NTG
FCCID: 2AY3Y-NTGA IC:23655-NTGA
See device label for details.

This control unit complies with part 15 of theFCC Rules.Operation is subject to the following two conditions: (1) This control unit may not cause harmful interference, and (2) this control unit must accept any interference received, including interference that may cause undesired operation. This control unit complies with Industry Canada licenseexempt RSS standard(s). Operation is subject to the following two conditions: (1) this control unit may not cause interference, and (2) this control unit must accept any interference, including interference that may cause undesired operation of the control unit.

This equipment complies with FCC/ISED radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines and RSS-102 of the ISED radiofrequency (RF) Exposure rules. This equipment has very low levels of RF energy that are deemed to comply without testing of specific absorption rate (SAR).

Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.

If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocatethe receiving antenna.
• Increasethe separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TVtechnician for help.

INTERNAL BATTERY INFORMATION

This Normatec Go control unit is equipped with a rechargeable lithium ion battery. The internal battery is designed to allow use of the Normatec Go System anywhere—even when power outlets aren’t available. The NormatecGo control unit may need to be charged before first use. A fully charged battery will provide power for up to 2 hours of cumulative run-time. It takes approximately 4 hours to fully charge the battery when the control unit is plugged in and not in use. Therechargeable lithium ion battery is intended to be changed only by authorized service personnel with the use of a special service tool.

PRODUCT SPECIFICATIONS

• Normatec Go Model: ALJ7
• Normatec Go Calf Wrap Dimensions (fully open): 25”(width), 1”(depth), 12”(height); [63.5 cm (width), 2.5 cm (depth), 30.5 cm (height)]
• Normatec Go Weight: 1.2 lbs [0.5 kg]
• Normatec Go electrical requirement: 5VDC 1 A
• Maximum Air Pressure: 220 mm Hg
• Temperature (operating): +41° F to 104° F [+5° C to +40° C]
• Temperature (storage): -13° F to+158° F [-25° C to+70° C]
• Relative Humidity (operating): 15%to 93%, non condensing
• Relative Humidity (storage): -25˚ C without relative humidity control; +70˚ C at relative humidity up to 93%, non-condensing
• Atmospheric pressure (storage andtransportation): 190hPa to 1060hPa
• Atmospheric pressure (operating): 700hPa to 1060hPa

ELECTROMAGNETIC COMPATIBILITY

The information contained in this section (such as separation distances) is in general specifically written with regard to the Normatec Go. The numbers provided will not guarantee faultless operation but should provide reasonable assurance of such. This information may not be applicable to other medical electrical equipment; older equipment may be particularly susceptible to interference.

GENERAL NOTES

Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this document and the remainder of the instructions for use of this control unit.

WARNING!

• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closerthan 30 cm (12 inches)to any part of the Normatec Go, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
• The Normatec Go should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the NormatecGo should be observed to verify normal operation. If operation is not normal, the Normatec Go or the other equipment should be moved.
• Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
• Avoid exposure to known sources of EMI (electromagnetic interference) such as diathermy, lithotripsy, electrocautery, RFID (Radio Frequency Identification), and electromagnetic security systems such as anti-theft/electronic article surveillance systems, metal detectors. Note that the presence of RFID devices may not be obvious. If such interference is suspected, reposition the equipment, if possible, to maximize distances.

ELECTROMAGNETIC EMISSIONS

This equipment is intended for use in the electromagnetic environment of clinics, hospitals, athlete training, or home environments. The user of this equipment should assure that it is used in such an environment.

internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
CISPR emissions classification| Class B| The equipment is suitable for use in all establishments, including domestic establishments and  those  directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions (IEC 61000-3-2)| Class A
Voltage fluctuations/ flicker (IEC 61000-3-3)| Complies

ELECTROMAGNETIC IMMUNITY

During the immunity testing described below the Normatec Go continued to provide therapy normally. This equipment is intended for use in the electromagnetic environment specified below. The user of this equipment should assure that it is used in such an environment.

Immunity Against| Compliance Level (of this control unit)| Electromagnetic Environment
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Electrostatic discharge, ESD (IEC 61000-4-2)| ± 8 kV direct| Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be kept at levels to reduce electrostatic charge to suitable levels.
Electrical fast transients/ bursts (IEC 61000-4-4)| ± 2 kV ± 2 kV| Mains power quality should be that of a typical clinic, hospital, athletic training, or home environment.
RF Proximity (IEC 61000-| Mains power quality should be that of  a typical clinic, hospital, athletic training, or home environment.| Equipment with high RF emissions should be kept at a distance to reduce the likelihood of interference.
Surges on AC mains lines (IEC 61000-4-5)| ± 2 kV| Mains power quality should be that of a typical clinic, hospital, athletic training, or home environment.
Power frequency magnetic field 50/60 Hz (IEC 61000-4-8)| 30 A/m| Equipment that emits high levels of power line magnetic fields (in excess of 3A/m) should be kept at a distance to reduce the likelihood of interference.
Voltage dips and short interruptions on AC mains input lines (IEC 61000-4-11)| 0.5 cycles 1 cycle
25 cycles (50 Hz)
30 cycles (60 Hz)
250 cycles (50 Hz)
300 cycles (60 Hz)| Mains power quality should be that of a typical clinic, hospital, athletic training, or home environment.  If you require continued operation during power mains interruptions, ensure that batteries are installed and charged. Ensure that battery life exceeds longest anticipated power outages or provide additional uninterruptible power source.

This equipment is intendedfor use in the electromagnetic environment specified below. The customer or the user of this equipment should assure that it is used in such an environment.

Conducted RF RF coupled into lines (IEC 61000-4-6)
Radiated RF (IEC 61000-4-3)| 3 Vrms
150 kHz to 80 MHz
6 Vrms in ISM bands
10 V/m 80 MHz to 2.7 GHz| This device is suitable for the electromagnetic environment of typical clinic, hospital, athletic training or home environments.

EQUIPMENT CLASSIFICATION

• Protection against electric shock: Class II/internally powered equipment
• Degree of protection against electric shock: Type BF applied part
• Ingress protection: IP22
• Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide
• Continuous operation

TROUBLESHOOTING

Press the power button to turn the control unit on. Check that the battery is charged.
The wrap does not inflate| The session has not been started
The wrap is punctured or damaged| Check that the start / stop LED is ON and the timer is counting down. If not, press start / stop button to start or resume session.
Check that there is no air leak error message on the display screen.
The system stopped pumping| The session has been stopped or has ended.| Check that the start / stop LED is ON and the timer is counting down. If not, press start / stop button to start or resume session.
Check that there is no air leak error message on the display screen.
Check that there is no Low Battery message on the display screen.
Air leak message: Air Leak| Air leak| Check for punctures in the wrap.
Low Battery| Battery needs to be charged| Plug in the control unit to charge the battery.
Cannot establish or maintain a Bluetooth connection| Bluetooth is turned off| Turn on Bluetooth on the phone attempting to pair with the Normatec Go control unit.

Call Hyperice customer service at +1.949.565.4994 if further assistance is needed.

WARRANTY INFORMATION

Please visit hyperice.com/warranty to reivew the warranty in your country.

OR

Normatec Go System Limited One-Year Warranty The Normatec Go control unit is warranted by Hyperice, Inc. a California corporation (“Hyperice”), against manufacturing defects in material and workmanship for a period of one yearfrom the date of purchase from Hyperice. In the event of any such defect occurring during the warranty period, Hyperice will, at its option, (a) correct the defect by repair or by replacement of the applicable part or component that fails as a result of such defect, without charge for parts and labor; or(b) replace the control unit with one of the same or then current design.

Thefore going Warranties do not cover normal wear and tear or cosmetic damage, and are void if the device and other accessories (collectively, the “product”) are not used in accordance with the user manual, are otherwise misused or modified in any way, and/or are repaired or altered by anyone other than an authorized service representative of Hyperice. These Warranties expressly exclude transportation, shipping orinsurance costs, or defects, damages, orfailure resulting from misuse, abuse, improper or abnormal usage, or neglect.

EXCEPT AS PROVIDED ABOVE, HYPERICE MAKES NOEXPRESS WARRANTIES ORANY IMPLIED WARRANTIES, INCLUDING THOSE OF MERCHANT ABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE, AND ARE LIMITED IN DURATION AS STATED ABOVE. EXCEPT AS EXPRESSLY STATED ABOVE, HYPERICE SHALL HAVE NO LIABILITY OR RESPONSIBILITY TO ITS CUSTOMER OR ANY OTHER PERSON OR ENTITY WITH RESPECT TO ANY LIABILITY, LOSS,OR DAMAGE CAUSED DIRECTLY OR INDIRECTLY BY USE OR PERFORMANCE OF THE PRODUCT OR ARISING OUT OF THE USE OR IN ABILITY TO USE THE PRODUCT OR ANY BREACH OF THESE WARRANTIES, INCLUDING BUT NOT LIMITED TO ANY DAMAGES RESULTING FROM INCONVENIENCE, LOSS OF TIME, PROPERTY, OR INCOME, OR ANY INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY KIND.

Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitations or exclusions may not apply to you. These Warranties give you specific legal rights, and you may also have other rights, which vary from state to state. In the event of a product defect covered by the foregoing Warranties during the applicable warranty period, contact Hyperice at +1.949.565.4994 or customersupport@hyperice.com. Allreplaced parts and products become the property of Hyperice. New or reconditioned parts and products may be used inthe performance of Warranty service. Repaired orreplaced parts and products are warranted for the remainder of the original warranty period only. You will be charged for repair or replacement of parts and products made after the expiration of the applicable Warranty period.

RETURN POLICY

This policy is only applicable if you are an end user and you purchased the equipment directly from Hyperice. In the unlikely event that you are not satisfied with your purchase, you may return it within thirty (30) days of the purchase date. All returns are subject to the conditions listed below.

• Returns must have a Return Merchandise Authorization (RMA) number. Obtain an RMA number by contacting us at +1.949.565.4994 or customersupport@hyperice.com. Returned items without an RMA number will not be eligible for a credit to your account.
• Returns must be shipped within 30 days of the purchase date.
• Products and packaging must be returned in new and undamaged condition.
• Any products showing signs of wear or being soiled in any way will be deemed “unacceptable,” and you will be so notified. Unacceptable returns may be reshipped to you following payment of an inspection/shipping fee.
• If you refuse delivery of your orderfor any reason, you will be refunded the cost of your order less shipping fees.
• All partial or full refunds will be posted to the credit card used for purchase.
• Hyperice is not responsible foritems lost or damaged during shipping.

FDA INFORMATION

MedWatch is the Food and Drug Administration’s (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics. If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor. Your health care provider can provide clinical information based on your medical record that can help FDA evaluate your report. However, we understand that for a variety of reasons, you may not wish to have the form filled out by health care provider, or your health care provider may choose not to complete the form. Your health care provider is NOT required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself. You will receive an acknowledgment from FDA when your report is received. Reports are reviewed by FDA staff. You will be personally contacted only if we need additional information.

SUBMITTING ADVERSE EVENT REPORTS TO FDA
Use one of the methods below to submit voluntary adverse event reports to the FDA:

a. Report online at: www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
b. Consumer Reporting Form FDA 3500B. Follow the instructions on the form to either fax or mail it in for submission. For help filling out the form, see MedWatchLearn. The form is available at: www.fda.gov/downloads/aboutFDA/reportsmanualsforms/forms/ucm349464.pdf
c.Call FDA at 1-800-FDA-1088 to report by telephone

Reporting Form FDA 3500 commonly used by heath professionals. The form is available at: www.fda.gov/downloads/aboutFDA/reportmanualsforms/forms/ucm163919.pdf

NormaTec Industries, LP
480 Pleasant Street, Suite A200
Watertown, Massachusetts 02472 USA
Copyright 2022 © Hyperice, Inc. All rights reserved.

hyperice.com

References

• hyperice.com
• MedWatch Online Voluntary Reporting Form

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