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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 K261061
Device Name BP Go (BPP-855)
Applicant
Wellvii, Inc.
4521 Pga Blvd., Pmb 341
Palm Beach Gardens,  FL  33418
Applicant Contact Mark Khachaturian
Correspondent
Wellvii, Inc.
4521 Pga Blvd., Pmb 341
Palm Beach Gardens,  FL  33418
Correspondent Contact Mark Khachaturian
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/31/2026
Decision Date 08/13/2026
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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