Pain Therapy Device

Stimulator, Muscle, Powered, For Muscle Conditioning

Guangzhou Xinbo Electronic Co., Ltd.

The following data is part of a premarket notification filed by Guangzhou Xinbo Electronic Co., Ltd. with the FDA for Pain Therapy Device.

Pre-market Notification Details

Device IDK202638
510k NumberK202638
Device Name:Pain Therapy Device
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Guangzhou Xinbo Electronic Co., Ltd. No.23 Building, The Second Phase, Huachuang Animation Industry Park, Panyu Guangzhou,  CN 511450
ContactSammy Li
CorrespondentCassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou,  CN 510000
Product CodeNGX  
Subsequent Product CodeGZJ
Subsequent Product CodeIPF
Subsequent Product CodeNUH
Subsequent Product CodeNYN
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-11
Decision Date2021-07-15

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