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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 K252422
Device Name Wearable Breast Pump (Model W2)
Applicant
Shenzhen TPH Technology Co., Ltd.
Rm.203, 2nd Flr, 29th Bldg, Lianchuang Technology Pk, #21
Bulan Rd., Xialilang Community, Nanwan St., Longgang Distric
Shenzhen,  CN 518000
Applicant Contact Dale Wang
Correspondent
Shenzhen TPH Technology Co., Ltd.
Rm.203, 2nd Flr, 29th Bldg, Lianchuang Technology Pk, #21
Bulan Rd., Xialilang Community, Nanwan St., Longgang Distric
Shenzhen,  CN 518000
Correspondent Contact Dale Wang
Regulation Number884.5160
Classification Product Code
HGX  
Date Received08/01/2025
Decision Date 02/13/2026
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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