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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 K252552
Device Name Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
Applicant
Shenzhen Changkun Technology Co., Ltd.
Rm. 101, Bldg. 1, 15 Xiusheng 2nd Rd., Xiuxin Community
Kengzi Subdistrict, Pingshan District
Shenzhen,  CN 518118
Applicant Contact Qingpeng Wang
Correspondent
Shenzhen Reanny Medical Devices Mgmt Consulting Co., Ltd.
Rm.1509, Jingting Bldg., Dongzhou Community, Guangming St.
Shenzhen,  CN 818000
Correspondent Contact Reanny Wang
Regulation Number876.5320
Classification Product Code
KPI  
Date Received08/13/2025
Decision Date 05/06/2026
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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