Therabody K210938 PowerDot Muscle Stimulator Instructions

Therabody K210938 PowerDot Muscle Stimulator

Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2023
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DEPARTMENT OF HEAL TH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

51 0(k) Number (if known) K210938

Device Name
PowerDot PD-01M2 Muscle Stimulator (with PowerDot Mobile Application)

Indications for Use (Describe)

PowerDot PD-01M2 is NMES/TENS stimulator with the following Over-The-Count indications for use: NMES

• Stimulation of healthy muscles in order to improve or facilitate muscle performance TENS
• Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities When prescribed by healthcare provider, in addition, PowerDot PD-01M2 Muscle Stimulator can be also used with the following additional Rx only indications for use:

NMES

• Retarding or preventing disuse atrophy
• Maintaining or increasing range of motion
• Re-educating muscles
• Relaxation of muscle spasms
• Increasing local blood circulation
• Prevention of venous thrombosis of the calf muscles immediately after surgery

TENS

• Symptomatic relief and management of chronic, intractable pain
• Post-surgical and post-trauma acute pain
• Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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