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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeNYY
Regulation Number 890.5850
Device Class 2