Clearance Summary
THERMO TRIM received FDA 510(k) clearance under submission number K852637, sponsored by Suntec Health & Fitness Group, 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 1985-11-20.
- Submission: K852637
- Applicant / Sponsor: Suntec Health & Fitness Group, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5740
- Decision date: 1985-11-20
Classification & Regulation
This clearance is catalogued under FDA product code IRT and 21 CFR 890.5740, within the Physical Medicine review panel as a Class II device.