Clearance Summary
VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE) received FDA 510(k) clearance under submission number K053503, sponsored by Vax-D Medical Technologies USA, L.C.. 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 2005-12-28.
- Submission: K053503
- Applicant / Sponsor: Vax-D Medical Technologies USA, L.C.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5900
- Decision date: 2005-12-28
Classification & Regulation
This clearance is catalogued under FDA product code ITH and 21 CFR 890.5900, within the Physical Medicine review panel as a Class II device.