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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 K232439
Device Name Electrical Stimulator System
Applicant
Gymmax Technology Shenzen Co., Ltd.
East 5f, A2 Bldg., Huimingsheng Dingfeng Technology Park,
Fuhai St., Fuyong Town, Baoan District
Shenzhen City,  CN 518103
Applicant Contact Benson Wang
Correspondent
Imd Medical & Drug Technology Services Institutions
Rm. 308, Bldg. 11, # 23 Jinqu Rd.
Wanjiang District, Dongguan City
Shenzhen City,  CN 518117
Correspondent Contact Salon Chen
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received08/14/2023
Decision Date 03/21/2024
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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