TENS/EMS device (GUSE01)— 510(k) K253896
Substantially EquivalentGlobalcare Medical Technology Co., Ltd.
FDA 510(k) clearance K253896 for TENS/EMS device (GUSE01), Substantially Equivalent on 2026-03-04. Applicant: Globalcare Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Globalcare Medical Technology Co., Ltd.
- Product code
- Product code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhongshan City, CN
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