PKS — Exerciser, Non-Measuring For Stroke Rehabilitation Class I
FDA product code PKS covers "Exerciser, Non-Measuring For Stroke Rehabilitation", a Class I medical device regulated under 21 CFR 890.5370. Submissions are reviewed by the Physical Medicine panel.
Classification Details
- Product Code
- PKS
- Device Class
- Class I
- Regulation Number
- 890.5370
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Definition
Non-measuring exercise equipment intended for medical purposes of facilitating stroke rehabilitation and maintaining or increasing range of motion.