Clearance Summary
BEWELL, MODEL SC 20 received FDA 510(k) clearance under submission number K043326, 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 2005-01-26.
- Submission: K043326
- Applicant / Sponsor: Cycling and Health Tech. Industry R&D Center
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3800
- Decision date: 2005-01-26
Classification & Regulation
This clearance is catalogued under FDA product code INI and 21 CFR 890.3800, within the Physical Medicine review panel as a Class II device.