Clearance Summary
THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202 received FDA 510(k) clearance under submission number K011768, sponsored by Thermo-Electric Co.. 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 2001-08-03.
- Submission: K011768
- Applicant / Sponsor: Thermo-Electric Co.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5100
- Decision date: 2001-08-03
Classification & Regulation
This clearance is catalogued under FDA product code LSB and 21 CFR 890.5100, within the Physical Medicine review panel as a Class II device.