Clearance Summary
MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 received FDA 510(k) clearance under submission number K092793, sponsored by Bio-Medical Research, 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 2009-12-07.
- Submission: K092793
- Applicant / Sponsor: Bio-Medical Research, Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2009-12-07
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.