Product code
ISH: Component, external, limb, ankle/foot
FDA product code · Class I · Physical Medicine
Key facts
| Product code | ISH |
|---|---|
| Device | Component, external, limb, ankle/foot |
| Device class | Class I |
| Regulation number | 890.3420 |
| Review panel | Physical Medicine |
| Medical specialty | Physical Medicine |
| Submission type | 510(K) Exempt |
| GMP exempt | Yes |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1,000+ UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 10–99 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