MStim Drop Model: LGT-233

Stimulator, Neuromuscular, External Functional

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 Mstim Drop Model: Lgt-233.

Pre-market Notification Details

Device IDK202110
510k NumberK202110
Device Name:MStim Drop Model: LGT-233
ClassificationStimulator, Neuromuscular, External Functional
Applicant Guangzhou Longest Science & Technology CO., Ltd. 5&6F, Building B4, No.11, Kaiyuan Avenue, Science City, Guangzhou Hi-tech In Guangzhou,  CN 510530
ContactXiaobing Luo
CorrespondentJet Li
Guangzhou Keda Biological Tech Co., Ltd. 6F, No. I TianTai Road, Science City, LuoGang District Guangzhou,  CN 510060
Product CodeGZI  
CFR Regulation Number882.5810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-30
Decision Date2021-11-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06971410780063 K202110 000
00692520001133 K202110 000
00692520001126 K202110 000
00692520001119 K202110 000
00692520001027 K202110 000
06976287180824 K202110 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.