Clearance Summary
REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM received FDA 510(k) clearance under submission number K111636, sponsored by Gunnell, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2012-04-03.
- Submission: K111636
- Applicant / Sponsor: Gunnell, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 2012-04-03
Classification & Regulation
This clearance is catalogued under FDA product code IOR and 21 CFR 890.3850, within the Physical Medicine review panel as a Class I device.