Clearance Summary
SANIDAD HEALTH-UP TENS MP-73725 received FDA 510(k) clearance under submission number K014126, sponsored by Roc Chinese-European Industrial Research Society. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2002-05-03.
- Submission: K014126
- Applicant / Sponsor: Roc Chinese-European Industrial Research Society
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2002-05-03
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.