Nerve And Muscle Stimulator

Stimulator, Muscle, Powered

Shenzhen XFT Medical Limited

The following data is part of a premarket notification filed by Shenzhen Xft Medical Limited with the FDA for Nerve And Muscle Stimulator.

Pre-market Notification Details

Device IDK211094
510k NumberK211094
Device Name:Nerve And Muscle Stimulator
ClassificationStimulator, Muscle, Powered
Applicant Shenzhen XFT Medical Limited Room 203, Building 1, Biomedicine Innovations Industrial Park, #14 Jinhui Road Shenzhen,  CN
ContactCindy Peng
CorrespondentField Fu
Shenzhen Joyantech Consulting Co., Ltd. 1713A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen,  CN
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-12
Decision Date2021-07-08

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