Clearance Summary
TENS/FES/NMES ELECTRODES received FDA 510(k) clearance under submission number K962332, sponsored by Uni-Patch, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1996-07-31.
- Submission: K962332
- Applicant / Sponsor: Uni-Patch, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 1996-07-31
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.