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FDA 510(k)

Coretech Compression System (Coretech RHB3003)

K-Number: K250817 · 2025-08-08

ApplicantVive Health, LLC
Decision Date2025-08-08
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Coretech Compression System (Coretech RHB3003) is a medical device manufactured by Vive Health, LLC. It received FDA 510(k) clearance on 2025-08-08 under approval number K250817. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Coretech Compression System (Coretech RHB3003)?

Coretech Compression System (Coretech RHB3003) is a medical device that received FDA 510(k) clearance on 2025-08-08. It is manufactured by Vive Health, LLC. The 510(k) number is K250817.

When was Coretech Compression System (Coretech RHB3003) approved by the FDA?

Coretech Compression System (Coretech RHB3003) received FDA 510(k) clearance on 2025-08-08, under approval number K250817.

What company makes Coretech Compression System (Coretech RHB3003)?

Coretech Compression System (Coretech RHB3003) is manufactured by Vive Health, LLC.

What is the FDA product code for Coretech Compression System (Coretech RHB3003)?

The FDA product code for Coretech Compression System (Coretech RHB3003) is JOW.

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Other Devices by Vive Health, LLC

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Related Devices (Code: JOW)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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