Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)

Stimulator, Muscle, Powered, For Muscle Conditioning

Guangzhou Longest Science & Technology Co., LTD.

The following data is part of a premarket notification filed by Guangzhou Longest Science & Technology Co., Ltd. with the FDA for Portable Electro-stimulation Therapy Device, Model: Lgt-232(us).

Pre-market Notification Details

Device IDK201845
510k NumberK201845
Device Name:Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Guangzhou Longest Science & Technology Co., LTD. 5 & 6f, Building B4, No. 11, Kaiyuan Avenue, Science City Guangzhou,  CN 510530
ContactXiaobing Luo
CorrespondentJet Li
Guangzhou KEDA Biological Tech Co., LTD. 6F, No. 1 TianTai Road, Science City, LuoGang District Guangzhou,  CN
Product CodeNGX  
Subsequent Product CodeNUH
Subsequent Product CodeNYN
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-06
Decision Date2020-10-08

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