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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 K250152
Device Name eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breast Pump S1 Pro (T8D04) Model T8D04; eufy Wearable Breast Pump E20 (T6060) Model T6060;
Applicant
Shenzhen TPH Technology Co., Ltd.
Rm. 203, 2nd Floor, 29th Bldg., Lianchuang Technology
Park, #21 Bulan Rd., Xialilang
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
Shenzhen,  CN 518100
Correspondent Contact Xiaoyan Yang
Regulation Number884.5160
Classification Product Code
HGX  
Date Received01/21/2025
Decision Date 04/02/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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