Muscle Trainer

Stimulator, Muscle, Powered, For Muscle Conditioning

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 Muscle Trainer.

Pre-market Notification Details

Device IDK181728
510k NumberK181728
Device Name:Muscle Trainer
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Shenzhen Kentro Medical Electronics Co., Ltd No.3, Xihu Industry Zone, Xikeng Village, Henggang Town, Longgang District Shenzhen,  CN 518115
ContactZewu Zhang
CorrespondentRain Yip
Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center, Guimiao Road Shenzhen,  CN 518000
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-29
Decision Date2018-10-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06924607701280 K181728 000
06924607701273 K181728 000
06924607701266 K181728 000
06924607701259 K181728 000
06924607701242 K181728 000
06924607701235 K181728 000
06924607701228 K181728 000
00850033118100 K181728 000

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