K253896
- 510(k) number
- K253896
- Device name
- TENS/EMS device (GUSE01)
- Applicant
- Globalcare Medical Technology Co., Ltd. CN
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2026-03-04
- Date received
- 2025-12-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253896.pdf
Official FDA record: K253896
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.