PKS
- Product code
- PKS
- Device name
- Exerciser, Non-Measuring For Stroke Rehabilitation
- Device class
- Class 1
- 21 CFR
- 21 CFR 890.5370
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K) Exempt
FDA classification definition
Non-measuring exercise equipment intended for medical purposes of facilitating stroke rehabilitation and maintaining or increasing range of motion.
Official FDA classification page: PKS
Classification and pathway per current FDA publications. Data from openFDA (CC0).