Dexus Prosthetics System (Model: MSL1, MSR1)

Electrode, Cutaneous

Zhejiang Qiangnao Technology Co.,Ltd

The following data is part of a premarket notification filed by Zhejiang Qiangnao Technology Co.,ltd with the FDA for Dexus Prosthetics System (model: Msl1, Msr1).

Pre-market Notification Details

Device IDK220002
510k NumberK220002
Device Name:Dexus Prosthetics System (Model: MSL1, MSR1)
ClassificationElectrode, Cutaneous
Applicant Zhejiang Qiangnao Technology Co.,Ltd Room 201-5, Building 1, No.1818-2, Wenyi West Road Yuhang Street, Yuhang District Hangzhou,  CN 310000
ContactBoyuan Meng
CorrespondentCassie Lee
Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou,  CN 510000
Product CodeGXY  
CFR Regulation Number882.1320 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-04
Decision Date2022-09-09

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