Clearance Summary
TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000 received FDA 510(k) clearance under submission number K862579, sponsored by Tru-Trac. 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 1986-08-06.
- Submission: K862579
- Applicant / Sponsor: Tru-Trac
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5900
- Decision date: 1986-08-06
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.