Clearance Summary
VAX-T PELVIC TRACTION BELT received FDA 510(k) clearance under submission number K894435, sponsored by Vat-Tech, 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 1989-08-03.
- Submission: K894435
- Applicant / Sponsor: Vat-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5900
- Decision date: 1989-08-03
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.