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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 K253283
Device Name Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)
Applicant
Shenzhen Root Innovation Technology Co., Ltd.
#2-201, Floor 2 Hasee Computer Bldg., # 2 Beier Rd.
Bantian St., Longgang
Shenzhen,  CN 518129
Applicant Contact Wendy Wen
Correspondent
Shenzhen Root Innovation Technology Co., Ltd.
#2-201, Floor 2 Hasee Computer Bldg., # 2 Beier Rd.
Bantian St., Longgang
Shenzhen,  CN 518129
Correspondent Contact Wendy Wen
Regulation Number884.5160
Classification Product Code
HGX  
Date Received09/29/2025
Decision Date 10/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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