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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Non-Implantable, For Incontinence
510(k) Number K220161
Device Name Biofeedback Nerve and Muscle Stimulator
Applicant
Shenzhen Konmed Technology Co., Ltd.
601, Bldg. B4, Shenchengtou Creative Factory Life Science
Park, Julongshan A Rd.
Shenzhen,  CN 518118
Applicant Contact ShuiShan Yin
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd.
Huangpu District
Guangzhou,  CN 510530
Correspondent Contact Cassie Lee
Regulation Number876.5320
Classification Product Code
KPI  
Subsequent Product Code
HCC  
Date Received01/20/2022
Decision Date 07/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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