Product code
PKS: Exerciser, non-measuring for stroke rehabilitation
FDA product code · Class I · Physical Medicine
Key facts
| Product code | PKS |
|---|---|
| Device | Exerciser, non-measuring for stroke rehabilitation |
| Device class | Class I |
| Regulation number | 890.5370 |
| 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 | Non-measuring exercise equipment intended for medical purposes of facilitating stroke rehabilitation and maintaining or increasing range of motion. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None 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