Foot Drop System (Model XFT-2001D)

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 Foot Drop System (model Xft-2001d).

Pre-market Notification Details

Device IDK162718
510k NumberK162718
Device Name:Foot Drop System (Model XFT-2001D)
ClassificationStimulator, Neuromuscular, External Functional
Applicant SHENZHEN XFT Medical Limited RM 203, BLD1, 14JINHUI ROAD, NEW DISTRICT Shenzhen,  CN
ContactJiang Xiaoying
CorrespondentJiang Xiaoying
SHENZHEN XFT Medical Limited RM 203, BLD1, 14JINHUI ROAD, NEW DISTRICT Shenzhen,  CN
Product CodeGZI  
CFR Regulation Number882.5810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-29
Decision Date2017-11-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970670070044 K162718 000

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