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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 K252831
Device Name Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
Applicant
Dolanvy (Suzhou) Medical Technology Co., Ltd.
Rm. 401, 402, Bldg. 1, # 69, Jiepu Rd.
Suzhou Industrial Park
Suzhou,  CN 215000
Applicant Contact Ji Lei
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Sandra Jiang
Regulation Number876.5320
Classification Product Code
KPI  
Date Received09/05/2025
Decision Date 04/28/2026
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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