Transcutaneous Electrical Nerve Stimulator, Model: KTR-405

Stimulator, Nerve, Transcutaneous, Over-the-counter

Shenzhen Kentro Medical Electronics Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Kentro Medical Electronics Co., Ltd. with the FDA for Transcutaneous Electrical Nerve Stimulator, Model: Ktr-405.

Pre-market Notification Details

Device IDK220998
510k NumberK220998
Device Name:Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Shenzhen Kentro Medical Electronics Co., Ltd. 2nd Floor No 11,Shanzhuang Road, Xikeng Village, Yuanshan Street, Longgang District Shenzhen,  CN 518100
ContactZewu Zhang
CorrespondentYvonne Liu
Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen,  CN 518052
Product CodeNUH  
Subsequent Product CodeGZJ
Subsequent Product CodeIPF
Subsequent Product CodeNGX
Subsequent Product CodeNYN
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-04
Decision Date2022-08-24

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