Clearance Summary
GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING) received FDA 510(k) clearance under submission number K032719, sponsored by Gemore Technology Co, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2003-12-10.
- Submission: K032719
- Applicant / Sponsor: Gemore Technology Co, Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2003-12-10
Classification & Regulation
This clearance is catalogued under FDA product code LIH and 21 CFR 882.5890, within the Neurology review panel as a Class II device.