NYY

Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation

Product code

NYY

Device name

Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation

Device class

Class 2

21 CFR

21 CFR 890.5850

Medical specialty

Physical Medicine

Marketing pathway

510(K)

Flag

Third-party review eligible

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).