PKS

Exerciser, Non-Measuring For Stroke Rehabilitation

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PKS
Classification and pathway per current FDA publications. Data from openFDA (CC0).