Clearance Summary
T.E.N.S. ELECTRODE NON-STERILE received FDA 510(k) clearance under submission number K881444, sponsored by Tens Accessories, 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 1988-06-10.
- Submission: K881444
- Applicant / Sponsor: Tens Accessories, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 1988-06-10
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.