Clearance Summary
REUSABLE MOIST HEAT PACK received FDA 510(k) clearance under submission number K791653, 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 1979-09-07.
- Submission: K791653
- Applicant / Sponsor: Tru-Eze Mfg. Co., Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5730
- Decision date: 1979-09-07
Classification & Regulation
This clearance is catalogued under FDA product code IMA and 21 CFR 890.5730, within the Physical Medicine review panel as a Class I device.