Biofeedback Nerve And Muscle Stimulator

Stimulator, Muscle, Powered

Shenzhen Konmed Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Konmed Technology Co., Ltd. with the FDA for Biofeedback Nerve And Muscle Stimulator.

Pre-market Notification Details

Device IDK202648
510k NumberK202648
Device Name:Biofeedback Nerve And Muscle Stimulator
ClassificationStimulator, Muscle, Powered
Applicant Shenzhen Konmed Technology Co., Ltd. 601, Building B4, Shenchengtou Creative Factory Life Science Park Shenzhen,  CN 518118
ContactTony No Last Name Provided
CorrespondentTracy Che
Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen,  CN 518052
Product CodeIPF  
Subsequent Product CodeHCC
Subsequent Product CodeKPI
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-11
Decision Date2020-12-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970935830543 K202648 000
06970935830536 K202648 000

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