Clearance Summary
LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK received FDA 510(k) clearance under submission number K091317, sponsored by Bio-Medical Research, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2009-06-25.
- Submission: K091317
- Applicant / Sponsor: Bio-Medical Research, Ltd.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2009-06-25
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.