Clearance Summary
Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 received FDA 510(k) clearance under submission number K251856, sponsored by Everyway Medical Instruments Co.,Ltd. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-11-21.
- Submission: K251856
- Applicant / Sponsor: Everyway Medical Instruments Co.,Ltd
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2025-11-21
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.