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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 K260178
Device Name Pelvic Muscle Trainer (KM510, KM516B)
Applicant
Shenzhen Konmed Technology Co., Ltd.
601, Bldg. B4, Shenchengtou Creative Factory Life Science Pk
Julongshan A Rd., Xiuxin Block, Kengzi St., Pingshan Distric
Shenzhen,  CN 518118
Applicant Contact Tong Yin
Correspondent
Guangzhou GLOMED Biological Technology 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  
Date Received01/21/2026
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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