K251856
- 510(k) number
- K251856
- Device name
- Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
- Applicant
- Everyway Medical Instruments Co.,Ltd TW
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2025-11-21
- Date received
- 2025-06-17
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251856.pdf
Official FDA record: K251856
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.