Clearance Summary
TENS/FES/NMES ELECTRODES received FDA 510(k) clearance under submission number K983097, 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 1999-09-17.
- Submission: K983097
- Applicant / Sponsor: Uni-Patch, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 1999-09-17
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.