Product code
PAE: Upper extremity prosthesis with multiple simultaneous degrees of freedom and controlled via cutaneous electromyography
FDA product code · Class II · Physical Medicine
Key facts
| Product code | PAE |
|---|---|
| Device | Upper extremity prosthesis with multiple simultaneous degrees of freedom and controlled via cutaneous electromyography |
| Device class | Class II |
| Regulation number | 890.3450 |
| 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 | Upper extremity prosthesis intended to replace partially or fully amputated or congenitally absent upper extremities and to provide multiple and simultaneous degrees of freedom and functionality. |
At a glance
- None 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1–9 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