Product code
OHI: Orthosis, foot drop
FDA product code · Class I · Physical Medicine
Key facts
| Product code | OHI |
|---|---|
| Device | Orthosis, foot drop |
| Device class | Class I |
| Regulation number | 890.3475 |
| Review panel | Physical Medicine |
| Medical specialty | Physical Medicine |
| Submission type | 510(K) Exempt |
| GMP exempt | Yes |
| Definition | Aid for drop foot or similar disorders which have a lack of ankle dorsiflexion. Indicated for foot raising paresis. |
At a glance
- 1–9 510(k) clearances
- None 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