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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 rehabilitation
Regulation Description Powered muscle stimulator.
Definition Used for muscle stimulation for rehabilitation. Device repeatedly contracts muscles by passing pulsed electrical current through cutaneous electrodes contacting the affected body area. Indicated for use as an adjunctive therapy in rehabilitation for medical purposes such as relaxation of muscle spasm, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
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 CodeNYY
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