Clearance Summary
WELL-TENS received FDA 510(k) clearance under submission number K002874, sponsored by Well-Life Consultant. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-07-27.
- Submission: K002874
- Applicant / Sponsor: Well-Life Consultant
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2001-07-27
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.