QKCClass II
Interactive Rehabilitation Exercise Device, Prescription Use
21 CFR 890.5360 / Physical Medicine
QKC is the FDA product code for Interactive Rehabilitation Exercise Device, Prescription Use, a class II device type, regulated under 21 CFR 890.5360. FDA's definition for this code reads: "A prescription device intended to provide interactive rehabilitation environment by providing exercises for users to perform". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- QKC
- Device name
- Interactive Rehabilitation Exercise Device, Prescription Use
- FDA definition
- A prescription device intended to provide interactive rehabilitation environment by providing exercises for users to perform.
- Regulation
- 21 CFR 890.5360
- Device class
- Class II
- Review panel
- Physical Medicine
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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