# K240011: Lymphedema Compression

- Pathway: 510(k) (Traditional)
- Applicant: Jkh Health Co., Ltd.
- Decided: Feb 23, 2024 after 52 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: 7 generations back to K915638 (1992). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200353: ManaFlow, Manamed, Inc. (2020) Summary page 4.

## Indications for use
The Lymphedema Compression is comprised of a gradient compression sleeve and a portable intermittent pump to provide graduated compression in both sustained and intermittent settings for use in both the hospital and outpatient setting. It is pre-set to the default setting of 50 mmHg that cannot be adjusted or can be adjusted by the physician to a pressure within the specified range. It is intended for use in: * Treatment of lymphedema » Treatment of chronic venous insufficiency » Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers * Reducing venous leg ulcer healing time * Reducing edema due to venous stasis * Enhancing venous return The device is intended for home, and hospital use.

Source page: https://510kreport.com/device/K240011
Methodology: https://510kreport.com/methodology