# K191441: Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)

- Pathway: 510(k) (Traditional)
- Applicant: Maxstar Industrial Co., Ltd.
- Decided: Mar 5, 2021 after 645 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: 9 generations back to K850316 (1985). 20 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182668: Rapid Reboot Compression Therapy System, Rapid Reboot Recovery Products, LLC (2018) Summary page 5.
- K193354: Air Compression Therapy Device, Shenzhen Dongjilian Electronics Co., Ltd. (2020). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K211460: Air Relax Plus Model AR-3.0 (2021), 1 descendant of its own
- K212491: Air Relax Pro Model AR-4.0 (2021), 0 descendants of its own

## Indications for use
Air Relax/Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Relax/ Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) simulates kneading and stroking of tissues by using an inflatable garment.

Source page: https://510kreport.com/device/K191441
Methodology: https://510kreport.com/methodology