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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K250817
Device Name Coretech Compression System (Coretech RHB3003)
Applicant
Vive Health, LLC
8955 Fontana Del Sol Way
Naples,  FL  34109
Applicant Contact Joe Fleming
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.5800
Classification Product Code
JOW  
Date Received03/18/2025
Decision Date 08/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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