K253896

Substantially Equivalent

TENS/EMS device (GUSE01)

Applicant: Globalcare Medical Technology Co., Ltd.
Product code: NUH
Advisory panel: Neurology
Date received: 2025-12-05
Decision date: 2026-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhongshan City, CN

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.