TENS & EMS Device

Stimulator, Nerve, Transcutaneous, Over-the-counter

SHenzhen Jianfeng Electronic Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Jianfeng Electronic Technology Co., Ltd. with the FDA for Tens & Ems Device.

Pre-market Notification Details

Device IDK202866
510k NumberK202866
Device Name:TENS & EMS Device
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant SHenzhen Jianfeng Electronic Technology Co., Ltd. #902,903 Jialingyu Industry Building, Dapu Road, Houting, Shajing Town Baoan District, Shenzhen City,  CN 518104
ContactFeng Wen
CorrespondentIris Lin
Intertek Testing Services Shenzhen Ltd. Guangzhou. Block E, No.7-2 Guangdong Software Science Park, Caipin Road Guangzhou Science City, Getdd,  CN 510700
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-28
Decision Date2021-05-19

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