Transcutaneous Electrical Applicator (TEA)

Stimulator, Nerve, Transcutaneous, Over-the-counter

Ningbo MedKinetic Medical Device Co., Ltd.

The following data is part of a premarket notification filed by Ningbo Medkinetic Medical Device Co., Ltd. with the FDA for Transcutaneous Electrical Applicator (tea).

Pre-market Notification Details

Device IDK212377
510k NumberK212377
Device Name:Transcutaneous Electrical Applicator (TEA)
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Ningbo MedKinetic Medical Device Co., Ltd. Lushan West Road 167-8, Ningbo Free Trade Zone(South) Ningbo,  CN 315806
ContactZhang Wei
CorrespondentZhang Wei
Shenzhen Reanny Medical Devices Management Consulting Co Ltd Ningbo MedKinetic Medical Device Co., Ltd. Lushan West Road 167-8, Ningbo Free Trade Zone(Sou Ningbo,  CN 315806
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-02
Decision Date2022-04-15

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