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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 K242725
Device Name Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
Applicant
Ningbo Youhe Electrical Appliance Technology Co., Ltd.
#567,Xintang Rd.,Fuhai Town
Cixi,  CN 315322
Applicant Contact Yun Jun Huang
Correspondent
Shanghai Qisheng Business Consulting Co., Ltd.
Rm. 1301, Bldg. 46, Jing Gu Zhong Rd. 58
Minhang District
Shanghai,  CN 200240
Correspondent Contact Daniel Qiu
Regulation Number884.5160
Classification Product Code
HGX  
Date Received09/10/2024
Decision Date 05/30/2025
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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