Clearance Summary
WARM & FORM KNEE SUPPORTS received FDA 510(k) clearance under submission number K820469, sponsored by Thermo-Mold Medical Products, Inc.. 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 1982-03-08.
- Submission: K820469
- Applicant / Sponsor: Thermo-Mold Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3475
- Decision date: 1982-03-08
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.