# K120166: Compressible Limb and Circulation Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Won Industrial Co.
- Decided: May 14, 2012 after 116 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K914774 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102319: Compressible Limb and Circulation Therapy System Model Wic-2008, Won Industrial Co. (2011) Summary page 1.

## Recalls of this device
- Jan 13, 2017 · Class II · Z-0204-2018: Distribution of unapproved devices with incorrect air compression level setup
- Jan 13, 2017 · Class II · Z-0205-2018: Distribution of unapproved devices with incorrect air compression level setup

## Indications for use
WIC-2008S is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as :Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

Source page: https://510kreport.com/device/K120166
Methodology: https://510kreport.com/methodology