FDA product code OAL: Exercise Equipment, Powered, Emg-Triggered
OAL is the FDA product code for exercise equipment, powered, emg-triggered. It is a Class II device, regulated under 21 CFR 890.1375 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under OAL. The average 510(k) review took 219 days (median 219).
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.
Classification
| Field | Value |
|---|---|
| Device name | Exercise Equipment, Powered, Emg-Triggered |
| Device class | Class II |
| Regulation | 21 CFR 890.1375 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OAL clearance
Top OAL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Myomo, Inc. | 1 | 2007-04-12 |
Most recent OAL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K062631 | Myomo, Inc. | MYOMO E100 | 2007-04-12 | 219 |
Recalls for OAL devices
openFDA lists no recalls for product code OAL.
Frequently asked questions
What is FDA product code OAL?
OAL is the FDA product code for exercise equipment, powered, emg-triggered. It is a Class II device, regulated under 21 CFR 890.1375 and reviewed by the Physical Medicine panel.
What device class is OAL?
Class II, regulation 21 CFR 890.1375. Typical premarket route: 510(k).
How long does a 510(k) take for product code OAL?
Across 1 cleared submissions the average was 219 days from receipt to decision (median 219).
Which companies have the most OAL clearances?
Myomo, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OAL
- Run a recall and safety report across every OAL manufacturer
- Watch product code OAL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Physical Medicine product codes · FDA product code lookup · 510(k) database search · 510(k) review times