Nerve And Muscle Stimulator

Stimulator, Neuromuscular, External Functional

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 IDK193276
510k NumberK193276
Device Name:Nerve And Muscle Stimulator
ClassificationStimulator, Neuromuscular, External Functional
Applicant Shenzhen XFT Medical Limited Room 203, Building 1, Biomedicine Innovations Industrial Park, #14 Jinhui Road Shenzhen,  CN 518118
ContactJulia Ye
CorrespondentYoyo Chen
Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town Shenzhen,  CN 518100
Product CodeGZI  
CFR Regulation Number882.5810 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-26
Decision Date2020-09-23

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