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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 K250207
Device Name eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)
Applicant
Anker Innovations Limited
Unit 56, 8th Floor, Tower 2, Admiralty Centre, 18 Harcourt R
Hong Kong,  CN
Applicant Contact Darren Li
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, Block A, Zhongguan Times Sq., Liuxian
Ave. Xili Town
Shenzhen,  CN 518000
Correspondent Contact Tracy Chen
Regulation Number884.5160
Classification Product Code
HGX  
Date Received01/24/2025
Decision Date 08/11/2025
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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