Clearance Summary
THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 received FDA 510(k) clearance under submission number K050701, sponsored by Bionix Development Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2005-04-01.
- Submission: K050701
- Applicant / Sponsor: Bionix Development Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2005-04-01
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.