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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 the device name listed in this FDA 510(k) record. The listed applicant is Vive Health, LLC. It received FDA 510(k) clearance on 2025-08-08 under 510(k) 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. The listed applicant is Vive Health, LLC. The 510(k) number is K250817.

When did Coretech Compression System (Coretech RHB3003) receive FDA 510(k) clearance?

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

Who is the listed applicant for Coretech Compression System (Coretech RHB3003)?

The FDA 510(k) record lists Vive Health, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Vive Health, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250729Power Wheelchair (MOB1107)

Related Devices (Code: JOW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd

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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