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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 K254000
Device Name Happy Health Blood Pressure Monitor
Applicant
Happy Health, Inc.
3200 Gracie Kiltz Ln., #301
Austin,  TX  78758
Applicant Contact Dustin Freckleton
Correspondent
Rx Device Consulting
353 Woburn St.
Lexington,  MA  02420
Correspondent Contact Rakesh M. Lal
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/15/2025
Decision Date 09/03/2026
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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