Product code
IMK: Wheelchair, stair climbing
FDA product code · Class II · Physical Medicine
Key facts
| Product code | IMK |
|---|---|
| Device | Wheelchair, stair climbing |
| Device class | Class II |
| Regulation number | 890.3890 |
| 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 | PMA To Be Filed by 7/12/00 (65 FR 19834 (4/13/00)) |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 1–9 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