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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, muscle, powered, with limited output, for muscle conditioning
Regulation Description Powered muscle stimulator.
Definition Used for muscle stimulation for muscle conditioning. Device repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes and into the body. Temporarily affects the stimulated muscles contractile properties, force output, and/or fatigue resistance. Not intended to be used for medical purposes (e.g., rehabilitation), for aesthetic purposes (e.g., changing the physical appearance of the muscle or body), or for the purpose of improving athletic performance.
Physical State Electrical stimulation unit with leads and cutaneous electrodes
Technical Method Stimulation of muscles using electrical current applied to electrodes on a patient's skin
Target Area Electrodes are placed on the skin overlying the muscle or motor nerve to be stimulated
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeNYZ
Premarket Review Neuromodulation and Physical Medicine Devices (DHT5B)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.5850
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons