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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 K253934
Device Name Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)
Applicant
Shenzhen Root Innovation Technology Co., Ltd.
#2-201, Floor 2 Hasee Computer Bldg.
# 2 Beier Rd., Bantian St., Longgang
Shenzhen,  CN 518219
Applicant Contact Haiyan Wen
Correspondent
Shenzhen Root Innovation Technology Co., Ltd.
#2-201, Floor 2 Hasee Computer Bldg.
# 2 Beier Rd., Bantian St., Longgang
Shenzhen,  CN 518219
Correspondent Contact Haiyan Wen
Regulation Number884.5160
Classification Product Code
HGX  
Date Received12/09/2025
Decision Date 03/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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