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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 K192201
Device Name Electrical Stimulator System
Applicant
Gymmax Technology Shenzen Co., Ltd.
East 5F, A2 Building, Huimingsheng DingFeng Technology Park,
Fuhai Street, Fuyong Town, Baoan District
ShenZhen city,  CN 518103
Applicant Contact Benson Wang
Correspondent
IMD Medical & Drug technology service institutions
Tianbao office room 225, Sha Tai Road No.209
ShenZhen city,  CN 518117
Correspondent Contact Salon Chen
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
NGX   NYN  
Date Received08/13/2019
Decision Date 06/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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