Clearance Summary
TRACTION ACCESSORIES received FDA 510(k) clearance under submission number K830244, sponsored by Warm & Form, Orthopedic Materials. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1983-03-09.
- Submission: K830244
- Applicant / Sponsor: Warm & Form, Orthopedic Materials
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5850
- Decision date: 1983-03-09
Classification & Regulation
This clearance is catalogued under FDA product code HST and 21 CFR 888.5850, within the Orthopedic review panel as a Class I device.