# K250817: Coretech Compression System (Coretech RHB3003)

- Pathway: 510(k) (Traditional)
- Applicant: Vive Health, LLC
- Decided: Aug 8, 2025 after 143 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K043423 (2005). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123959: Circuflow 5150, Devon Medical, Inc. (2013) Summary page 5.

## Indications for use
The Coretech Compression System RHB3003 is a sequential compression device which is intended for treatment of patients with the following conditions: - Lymphedema - Venous stasis ulcers - Venous insufficiency - Peripheral edema The device is safe for both home and hospital use.

Source page: https://510kreport.com/device/K250817
Methodology: https://510kreport.com/methodology