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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K262654
Device Name Dexus Prosthetic System (MSL2, MSR2)
Applicant
Zhejiang Qiangnao Technology Co.,Ltd
Rm. 201-5, Bldg. 1, #1818-2, Wenyi W. Rd., Yuhang St., Yuhan
Hangzhou,  CN 310000
Applicant Contact Guifang Dai
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plz., Shuixi Rd.,
Huangpu District
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
IQZ  
Date Received07/30/2026
Decision Date 08/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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