Clearance Summary
MARUKYR-BAN / HOT OR HEAT PACK received FDA 510(k) clearance under submission number K850566, sponsored by Oriental Medical Supplies, 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 1985-05-29.
- Submission: K850566
- Applicant / Sponsor: Oriental Medical Supplies, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5710
- Decision date: 1985-05-29
Classification & Regulation
This clearance is catalogued under FDA product code IMD and 21 CFR 890.5710, within the Physical Medicine review panel as a Class I device.