Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation
NYY · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.5850
Classification
FDA Product Code
NYY
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 890.5850
Review panel
PM
Medical specialty
Physical Medicine
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.