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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 K251581
Device Name Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
Applicant
Shenzhen Hingmed Medical Instrument Co., Ltd.
4th Floor, Zhonghangfeixiang Bldg., # 371
Guangshen Rd., Baoan District
Shenzhen,  CN 518103
Applicant Contact Dien Wang
Correspondent
Shenzhen Hingmed Medical Instrument Co., Ltd.
4th Floor, Zhonghangfeixiang Bldg., # 371
Guangshen Rd., Baoan District
Shenzhen,  CN 518103
Correspondent Contact Dien Wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/23/2025
Decision Date 02/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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