Clearance Summary
ROTATION BOOT received FDA 510(k) clearance under submission number K823160, sponsored by Warm & Form, Orthopedic Materials. 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 1982-11-10.
- Submission: K823160
- Applicant / Sponsor: Warm & Form, Orthopedic Materials
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3475
- Decision date: 1982-11-10
Classification & Regulation
This clearance is catalogued under FDA product code IQI and 21 CFR 890.3475, within the Physical Medicine review panel as a Class I device.