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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 K221598
Device Name Wearable breast pump
Applicant
Mayborn (Uk) Limited
Mayborn House Balliol Business Park,
Newcastle Upon Tyne,,  GB NE12 8EW
Applicant Contact Sean Neasham
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm. 1308, Baohua International Plz.
555 W. Guangzhong Rd.
Shanghai,  CN 200072
Correspondent Contact Amber Pang
Regulation Number884.5160
Classification Product Code
HGX  
Date Received06/02/2022
Decision Date 12/09/2022
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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