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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 K253072
Device Name Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D)
Applicant
Linhejiacheng (Shenzhen) E-Commerce Co., Ltd.
# 808, 8f, Hasee Computer Bldg., Marie Curie Ave., 
Vanke City Community, Bantian St., Longgang District
Shenzhen,  CN 518000
Applicant Contact Caitlin Liang
Correspondent
Linhejiacheng (Shenzhen) E-Commerce Co., Ltd.
# 808, 8f, Hasee Computer Bldg., Marie Curie Ave., 
Vanke City Community, Bantian St., Longgang District
Shenzhen,  CN 518000
Correspondent Contact Caitlin Liang
Regulation Number884.5160
Classification Product Code
HGX  
Date Received09/23/2025
Decision Date 12/23/2025
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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