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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 K252769
Device Name Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)
Applicant
Shenzhen Finicare Co., Ltd.
201 And 301 Of Bldg. A22, Bldg. A22 And A23, #4
Industrial Park, Tantou Cmty, Songgang St.,Bao'An Dist,
Shenzhen,  CN 518105
Applicant Contact Li Chao
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lujiazui Rd.
Pudong Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/02/2025
Decision Date 10/02/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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