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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 K261199
Device Name Wearable Breast Pump (Model S32A)
Applicant
Shenzhen TPH Technology Co., Ltd.
Rm. 203, 2nd Floor, 29th Bldg., Lianchuang Technology Park
#21 Bulan Rd., Xialilang Community, Nanwan St., Longgang
Shenzhen,  CN 518100
Applicant Contact Dale WANG
Correspondent
Shenzhen TPH Technology Co., Ltd.
Rm. 203, 2nd Floor, 29th Bldg., Lianchuang Technology Park
#21 Bulan Rd., Xialilang Community, Nanwanstreet, Longgang
Shenzhen,  CN 518100
Correspondent Contact Dale WANG
Regulation Number884.5160
Classification Product Code
HGX  
Date Received04/13/2026
Decision Date 07/13/2026
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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