Clearance Summary
OTC Combo TENS/EMS System received FDA 510(k) clearance under submission number K172809, sponsored by Well-Life Healthcare Limited. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2017-10-18.
- Submission: K172809
- Applicant / Sponsor: Well-Life Healthcare Limited
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2017-10-18
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.