Electrical Stimulator System

Stimulator, Nerve, Transcutaneous, Over-the-counter

Gymmax Technology Shenzen Co., Ltd.

The following data is part of a premarket notification filed by Gymmax Technology Shenzen Co., Ltd. with the FDA for Electrical Stimulator System.

Pre-market Notification Details

Device IDK192201
510k NumberK192201
Device Name:Electrical Stimulator System
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Gymmax Technology Shenzen Co., Ltd. East 5F, A2 Building, Huimingsheng DingFeng Technology Park, Fuhai Street, Fuyong Town, Baoan District Shenzhen City,  CN 518103
ContactBenson Wang
CorrespondentSalon Chen
IMD Medical & Drug Technology Service Institutions Tianbao Office Room 225, Sha Tai Road No.209 Shenzhen City,  CN 518117
Product CodeNUH  
Subsequent Product CodeNGX
Subsequent Product CodeNYN
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-13
Decision Date2020-06-12

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