← FDA Medical Device Classifications
Interactive Rehabilitation Exercise Device, Prescription Use
QKC · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.5360
Classification
- FDA Product Code
QKC- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 890.5360
- Review panel
- PM
- Medical specialty
- Physical Medicine
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
A prescription device intended to provide interactive rehabilitation environment by providing exercises for users to perform.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 38
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown