Product code
PCE: Permanently mounted wheelchair platform lift
FDA product code · Class II · Physical Medicine
Key facts
| Product code | PCE |
|---|---|
| Device | Permanently mounted wheelchair platform lift |
| Device class | Class II |
| Regulation number | 890.3930 |
| Review panel | Physical Medicine |
| Medical specialty | Physical Medicine |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Intended for medical purposes to provide a guided platform to move a person with impaired mobility, with or without a wheelchair, from one level to another. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 100–999 UDI devices (GUDID)
- 10–99 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