Clearance Summary
WHEELCHAIR, MODEL 8500-II received FDA 510(k) clearance under submission number K043332, sponsored by Cycling and Health Tech. Industry R&D Center. 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 2004-12-13.
- Submission: K043332
- Applicant / Sponsor: Cycling and Health Tech. Industry R&D Center
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 2004-12-13
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.