OAL — Exercise Equipment, Powered, Emg-Triggered Class II
FDA product code OAL covers "Exercise Equipment, Powered, Emg-Triggered", a Class II medical device regulated under 21 CFR 890.1375. Submissions are reviewed by the Physical Medicine panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OAL
- Device Class
- Class II
- Regulation Number
- 890.1375
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K062631 | myomo | MYOMO E100 | April 12, 2007 |