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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 K253133
Device Name Wrist Blood Pressure Monitor (BPM-W1VL)
Applicant
Shenzhen Imdk Medical Technology Co., Ltd.
904, 9f, Guangming Tianan Cloud Park Bldg. 255 Zhenmei Rd.
Zhenmei Community, Xinhu St., Guangming District
Shenzhen,  CN 518107
Applicant Contact Yuan Xia
Correspondent
Qimmiq Medical Consulting Service Co., Ltd.
Rm.406, Bldg. C, Run Science Park
Guangzhou,  CN 510663
Correspondent Contact Yijie You
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/25/2025
Decision Date 02/13/2026
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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