# K173158: Air Relax

- Pathway: 510(k) (Special)
- Applicant: Maxstar Industrial Co., Ltd.
- Decided: May 30, 2019 after 608 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
Longest line of descent: 1 generation back to K130385 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130385: Compressible Limb Sleeve System, Maxstar Industrial Co., Ltd. (2014) Summary page 4.

## Indications for use
UAM-8100, UAM-8100N 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/K173158
Methodology: https://510kreport.com/methodology