Clearance Summary
MOIST HEAT PACK received FDA 510(k) clearance under submission number K803177, sponsored by Duro-Med Ind., 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 1980-12-31.
- Submission: K803177
- Applicant / Sponsor: Duro-Med Ind., Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5730
- Decision date: 1980-12-31
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.