Exerciser, Non-Measuring for Stroke Rehabilitation

What Is This Device?

Non-measuring exercise equipment intended for medical purposes of facilitating stroke rehabilitation and maintaining or increasing range of motion.

How Is PKS Classified?

Exerciser, Non-Measuring For Stroke Rehabilitation is FDA product code PKS, Class 1, 21 CFR 890.5370.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.