Clearance Summary
STEAM PAK MOIST HEAT received FDA 510(k) clearance under submission number K832803, sponsored by Electro-Med Health Industries, 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 1983-09-20.
- Submission: K832803
- Applicant / Sponsor: Electro-Med Health Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5730
- Decision date: 1983-09-20
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.