# K211200: WoundExpress

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare, Ltd.
- Decided: Sep 3, 2021 after 134 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: 6 generations back to K915638 (1992). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110159: Activecare SFT, Medical Compression Systems (Dbn), Ltd. (2011) Summary page 5.
- K193020: VenaPro Vascular Therapy System, Innovamed Health, LLC (2019) Summary page 5.

## Indications for use
WoundExpress aids in the treatment of the following clinical conditions: - Chronic wounds including leg ulcers (venous leg ulcers and mixed aetiology leg ulcers) - The management of lower limb pain

Source page: https://510kreport.com/device/K211200
Methodology: https://510kreport.com/methodology