NYY — Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation Class II
FDA product code NYY covers "Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation", a Class II medical device regulated under 21 CFR 890.5850. Submissions are reviewed by the Physical Medicine panel.
Classification Details
- Product Code
- NYY
- Device Class
- Class II
- Regulation Number
- 890.5850
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
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.