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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 K254300
Device Name eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009)
Applicant
Anker Innovations Limited
Unit 56, 8th Floor, Tower 2, Admiralty Centre
18 Harcourt Rd.
Hong Kong,  HK
Applicant Contact Ezra Zeng
Correspondent
Anker Innovations Limited
Unit 56, 8th Floor, Tower 2, Admiralty Centre
18 Harcourt Rd.
Hong Kong,  HK
Correspondent Contact Ezra Zeng
Regulation Number884.5160
Classification Product Code
HGX  
Date Received12/31/2025
Decision Date 05/29/2026
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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