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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K240236
Device Name Happy Ring Health Monitoring System
Applicant
Happy Health Inc.
3200 Gracie Kiltz Ln, #301
Austin,  TX  78758
Applicant Contact Dustin Freckleton
Correspondent
Rx Device Consulting
7 Courtyard Pl
Lexington,  MA  02420
Correspondent Contact Rakesh Lal
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
BZQ   DQA   DRG   FLL   GZO  
LEL  
Date Received01/29/2024
Decision Date 09/24/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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