# K212491: Air Relax Pro Model AR-4.0

- Pathway: 510(k) (Traditional)
- Applicant: Diode Art Engineering Doing Business AS Air Relax
- Decided: Sep 2, 2021 after 24 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: 11 generations back to K850316 (1985). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211460: Air Relax Plus Model AR-3.0, Diode Art Engineering Doing Business AS Air Relax (2021) Summary page 4.

## Indications for use
The Air Relax Pro Model AR-4.0 is intended 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 Pro Model AR-4.0 simulates kneading and stroking of tissues by using an inflatable garment.

Source page: https://510kreport.com/device/K212491
Methodology: https://510kreport.com/methodology