Needle Stimulator

Stimulator, Electro-acupuncture

Wuxi Jiajian Medical Instrument Co., Ltd

The following data is part of a premarket notification filed by Wuxi Jiajian Medical Instrument Co., Ltd with the FDA for Needle Stimulator.

Pre-market Notification Details

Device IDK202861
510k NumberK202861
Device Name:Needle Stimulator
ClassificationStimulator, Electro-acupuncture
Applicant Wuxi Jiajian Medical Instrument Co., Ltd No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi,  CN 214116
ContactCaihong Sun
CorrespondentCaihong Sun
Wuxi Jiajian Medical Instrument Co., Ltd No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi,  CN 214116
Product CodeBWK  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-28
Decision Date2021-08-27

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