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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K261082
Device Name Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)
Applicant
Microlife Corporation
9f, 431, Ruiguang Rd., Neihu Taipei 11492, Taiwan, China
Taipei,  CN
Applicant Contact Jimmy Deng
Correspondent
Mdi Consultants, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact Vaibhav Arvind Rajal
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/01/2026
Decision Date 07/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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