OAL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Exercise Equipment, Powered, Emg-Triggered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1375
- Medical specialty
- Physical Medicine
- FDA definition
- To provide rehabilitation (e.G., increasing range of motion, muscle re-education) through emg-triggered powered exercise. Increasing range of motion and muscle re-education.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| MYOMO E100 (K062631) | Myomo, Inc. | 2007-04-12 | + Add |
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