Product code
OAL: Exercise equipment, powered, emg-triggered
FDA product code · Class II · Physical Medicine
Key facts
| Product code | OAL |
|---|---|
| Device | Exercise equipment, powered, emg-triggered |
| Device class | Class II |
| Regulation number | 890.1375 |
| Review panel | Physical Medicine |
| Medical specialty | Physical Medicine |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | 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. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database