Clearance Summary
THERMASSAGE ENERGY PRODUCT, MODEL HY5000 received FDA 510(k) clearance under submission number K032449, sponsored by Migun Medical Instrument Co. , Ltd.. 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 2003-10-22.
- Submission: K032449
- Applicant / Sponsor: Migun Medical Instrument Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5880
- Decision date: 2003-10-22
Classification & Regulation
This clearance is catalogued under FDA product code JFB and 21 CFR 890.5880, within the Physical Medicine review panel as a Class II device.