Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation
NYY is the FDA product code for Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation, a class II device type, regulated under 21 CFR 890.5850. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- NYY
- Device name
- Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation
- FDA 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.
- Regulation
- 21 CFR 890.5850
- Device class
- Class II
- Review panel
- Physical Medicine
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code NYY.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.