QKC — Interactive Rehabilitation Exercise Device, Prescription Use Class II

FDA Device Classification

FDA product code QKC covers "Interactive Rehabilitation Exercise Device, Prescription Use", a Class II medical device regulated under 21 CFR 890.5360. Submissions are reviewed by the Physical Medicine panel.

Classification Details

Product Code
QKC
Device Class
Class II
Regulation Number
890.5360
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Definition

A prescription device intended to provide interactive rehabilitation environment by providing exercises for users to perform.