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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Powered
510(k) Number K252754
Device Name Wearable Electric Breast Pump (YM-8803)
Applicant
Guangdong Youmeng Electrical Technology Co., Ltd.
One Of Area A, Level 3, Bldg. 2, # 17, Keyuan 3rd Rd.
Xiaohuangpu Community, Ronggui St., Shunde District
Foshan,  CN 528303
Applicant Contact Zongjun Liu
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number884.5160
Classification Product Code
HGX  
Date Received08/29/2025
Decision Date 12/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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