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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 K260239
Device Name Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)
Applicant
Jiangxi AOV Maternity & Baby Products Co., Ltd.
8. Nanhuan Rd., Industrial Park
Guixi,  CN 335400
Applicant Contact Liben Chen
Correspondent
Jiangxi AOV Maternity & Baby Products Co., Ltd.
8. Nanhuan Rd., Industrial Park
Guixi,  CN 335400
Correspondent Contact Liben Chen
Regulation Number884.5160
Classification Product Code
HGX  
Date Received01/26/2026
Decision Date 04/22/2026
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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