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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K253896
Device Name TENS/EMS device (GUSE01)
Applicant
Globalcare Medical Technology Co., Ltd.
7th Bldg., 39 Middle Industrial Main Rd.,
European Industrial Zone Xiaolan Town
Zhongshan City,  CN 528415
Applicant Contact Valentina Sassi
Correspondent
Globalcare Medical Technology Co., Ltd.
7th Bldg., 39 Middle Industrial Main Rd.,
European Industrial Zone Xiaolan Town
Zhongshan City,  CN 528415
Correspondent Contact Nathifa Bradshaw
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received12/05/2025
Decision Date 03/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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