Clearance Summary
CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES received FDA 510(k) clearance under submission number K070807, sponsored by Pepin Mfg., Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2007-05-23.
- Submission: K070807
- Applicant / Sponsor: Pepin Mfg., Inc.
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2007-05-23
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.