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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 K260538
Device Name Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )
Applicant
Shenzhen Root Innovation Technology Co., Ltd.
#2-201, Floor 2 Hasee Computer Bldg., # 2 Beier Rd., Bantian
Shenzhen,  CN 518129
Applicant Contact Baihan Feng
Correspondent
Shenzhen Root Innovation Technology Co., Ltd.
#2-201, Floor 2 Hasee Computer Bldg., # 2 Beier Rd., Bantian
Shenzhen,  CN 518129
Correspondent Contact Baihan Feng
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/17/2026
Decision Date 06/17/2026
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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