510(k) K062631
K062631 is an FDA 510(k) premarket notification submitted by Myomo, Inc. for the device "MYOMO E100". The FDA issued a decision of Substantially Equivalent on April 12, 2007. The device falls under product code OAL (Exercise Equipment, Powered, Emg-Triggered), a Class II device regulated under 21 CFR 890.1375.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2007
- Date Received
- September 5, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Exercise Equipment, Powered, Emg-Triggered
- Device Class
- Class II
- Regulation Number
- 890.1375
- Review Panel
- PM
- Submission Type
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.