Exercise Equipment, Powered, Emg-Triggered
The Exercise Equipment, Powered, EMG-Triggered (product code OAL) is a powered rehabilitation device that uses electromyography (EMG) signals to trigger and control powered exercise, intended to provide rehabilitation benefits including increased range of motion and muscle re-education. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 890.1375 within the Physical Medicine specialty. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OAL
- Device Class
- FDA class 2
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K062631 | MYOMO E100 | Apr 12, 2007 | Substantially Equivalent | Myomo, Inc. |