Clearance Summary
VIBRA-TRAC TRACTION TABLE received FDA 510(k) clearance under submission number K895382, sponsored by Vibra-Trac Industries. 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 1989-10-16.
- Submission: K895382
- Applicant / Sponsor: Vibra-Trac Industries
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5925
- Decision date: 1989-10-16
Classification & Regulation
This clearance is catalogued under FDA product code ILZ and 21 CFR 890.5925, within the Physical Medicine review panel as a Class I device.