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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 K250383
Device Name Wearable Breast Pump (Model W6)
Applicant
Shenzhen TPH Technology Co., Ltd.
Rm.203, 2nd Floor, 29th Bldg., Lianchuang Technology Park
#21 Bulan Rd., Xialilang Community, Nanwan St., Longgang Dis
Shenzhen,  CN 518100
Applicant Contact Xiaoyan Yang
Correspondent
Shenzhen TPH Technology Co., Ltd.
Rm.203, 2nd Floor, 29th Bldg., Lianchuang Technology Park
#21 Bulan Rd., Xialilang Community, Nanwan St., Longgang Dis
Shenzhen,  CN 518100
Correspondent Contact Xiaoyan Yang
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/11/2025
Decision Date 08/20/2025
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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