Transcutaneous Electrical Nerve Stimulator Model: ST-304

Stimulator, Nerve, Transcutaneous, Over-the-counter

Shenzhen Future Electronic Co., Ltd

The following data is part of a premarket notification filed by Shenzhen Future Electronic Co., Ltd with the FDA for Transcutaneous Electrical Nerve Stimulator Model: St-304.

Pre-market Notification Details

Device IDK221092
510k NumberK221092
Device Name:Transcutaneous Electrical Nerve Stimulator Model: ST-304
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Shenzhen Future Electronic Co., Ltd Bldg B. Qiangchengda Industrial Park, No. 30, Youtian Road, Longgang District Shenzhen,  CN 518116
ContactZhao Qihong
CorrespondentYou Yijie
Qimmiq Medical Consulting Service Co., Ltd RM. 1711, Building K, NO. 101 Science Ave International Creative Valley Guangzhou,  CN 510663
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-13
Decision Date2022-09-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06959557200354 K221092 000
05060823620293 K221092 000

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