Clearance Summary
TRU-KINETICS (TM) received FDA 510(k) clearance under submission number K862780, 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 1986-08-04.
- Submission: K862780
- Applicant / Sponsor: Tru-Trac
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1925
- Decision date: 1986-08-04
Classification & Regulation
This clearance is catalogued under FDA product code IKK and 21 CFR 890.1925, within the Physical Medicine review panel as a Class II device.