# K130385: Compressible Limb Sleeve System

- Pathway: 510(k) (Traditional)
- Applicant: Maxstar Industrial Co., Ltd.
- Decided: Feb 18, 2014 after 368 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K173158: Air Relax (2019), 0 descendants of its own

## Indications for use
UAM-8 100 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, Postimrnobilization edema, Venous insufficiencies, Lymphedema.

Source page: https://510kreport.com/device/K130385
Methodology: https://510kreport.com/methodology