Coretech Compression System (Coretech RHB3003)— 510(k) K250817

Name: FDA 510(k) clearance K250817
Creator: U.S. Food and Drug Administration
Published: 2025-08-08

Substantially Equivalent

Vive Health, LLC

FDA 510(k) clearance K250817 for Coretech Compression System (Coretech RHB3003), Substantially Equivalent on 2025-08-08. Applicant: Vive Health, LLC. Device class: 2.

Clearance details

Applicant: Vive Health, LLC
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2025-03-18
Decision date: 2025-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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