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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 K261025
Device Name Wearable breast pump (QY-101, QY-102, QY-108)
Applicant
Shenzhen Qinyi Electronic Technology Co., Ltd.
601, 6th Floor, Bldg. C3, Chen Wenli Industrial Park,#289 Lo
Loucun Community, Xinhusub-District, Guangming District
Shenzhen,  CN 518100
Applicant Contact Chen Gu
Correspondent
Huide Medical Technology Service Group Co., Ltd.
Rm. 703, Bldg. 16, S. Bank Plz., Exhibition Bay
Zhancheng Community,Fuhai St., Bao'An District,
Shenzhen,  CN 518103
Correspondent Contact Amos Zou
Regulation Number884.5160
Classification Product Code
HGX  
Date Received03/30/2026
Decision Date 06/25/2026
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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