21 CFR 890.5850 - Powered muscle stimulator.

Code of Federal Regulations - Title 21: Food and Drugs

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Title 21: Food and Drugs

CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H: MEDICAL DEVICES

PART 890: PHYSICAL MEDICINE DEVICES

Subpart F: Physical Medicine Therapeutic Devices

890.5850 - Powered muscle stimulator.

(a) Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

(b) Classification. Class II (performance standards).

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