Clearance Summary
MEDICOM, TENS ELECTRODES received FDA 510(k) clearance under submission number K965194, sponsored by Medicotest A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1997-03-06.
- Submission: K965194
- Applicant / Sponsor: Medicotest A/S
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 1997-03-06
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.