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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 K233576
Device Name Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)
Applicant
Shenzhen Konmed Technology Co., Ltd.
601, Bldg. B4, Shenchengtou Creative Factory Life Science
Park, Julongshan A Rd., Xiuxin Block, Kengzi St.
Pingshan District, Shenzhen,  CN 518118
Applicant Contact Shuishan Yin
Correspondent
Guangzhou Glomed Biological Technoloy Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd., Huangpu
District
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number876.5320
Classification Product Code
KPI  
Subsequent Product Code
HIR  
Date Received11/07/2023
Decision Date 02/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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