Clearance Summary
THERMOLATOR HEATING UNIT received FDA 510(k) clearance under submission number K801625, sponsored by Tru-Eze Mfg. Co., 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 1980-07-28.
- Submission: K801625
- Applicant / Sponsor: Tru-Eze Mfg. Co., Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5950
- Decision date: 1980-07-28
Classification & Regulation
This clearance is catalogued under FDA product code IRQ and 21 CFR 890.5950, within the Physical Medicine review panel as a Class I device.