Clearance Summary
WHEEL-O-VATOR received FDA 510(k) clearance under submission number K934553, sponsored by The National Wheel-O-Vator Co., 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 1994-02-17.
- Submission: K934553
- Applicant / Sponsor: The National Wheel-O-Vator Co., Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3930
- Decision date: 1994-02-17
Classification & Regulation
This clearance is catalogued under FDA product code ING and 21 CFR 890.3930, within the Physical Medicine review panel as a Class II device.