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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 K253126
Device Name Wrist Blood Pressure Monitor (XW-05)
Applicant
Shenzhen Ziqing Medical Equipment Co., Ltd.
201, Bldg. 2, #1 Chuangye Rd., Shijing Community
Shijing St., Pingshan District
Shenzhen,  CN 518118
Applicant Contact Yongsheng Chen
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/25/2025
Decision Date 06/18/2026
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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