Clearance Summary
Therm-X received FDA 510(k) clearance under submission number K190854, sponsored by Zenith Technical Innovations. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2019-05-10.
- Submission: K190854
- Applicant / Sponsor: Zenith Technical Innovations
- Clearance pathway: Abbreviated
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5650
- Decision date: 2019-05-10
Classification & Regulation
This clearance is catalogued under FDA product code IRP and 21 CFR 890.5650, within the Physical Medicine review panel as a Class II device.