Clearance Summary
WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A received FDA 510(k) clearance under submission number K161453, sponsored by Well-Life Healthcare Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2016-12-05.
- Submission: K161453
- Applicant / Sponsor: Well-Life Healthcare Limited
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2016-12-05
Classification & Regulation
This clearance is catalogued under FDA product code NUH and 21 CFR 882.5890, within the Neurology review panel as a Class II device.