# K222823: AeroDVx Arm System

- Pathway: 510(k) (Traditional)
- Applicant: Sun Scientific, Inc.
- Decided: Sep 7, 2023 after 353 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K944567 (1995). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210885: Dayspring, Koya Medical, Inc. (2021) Summary page 4.

## Indications for use
The AeroDVx™ Arm System is comprised of a gradient compression sleeve, portable intermittent pneumatic pump and hand pump designed to provide static or intermittent pneumatic compression to the bicep and forearm, in both a clinical and outpatient setting. It is intended to provide treatment for: • Enhancement of blood circulation • Reduction of post-operative pain and swelling • Reduction of edema • Lymphedema • Post immobilization edema • Post mastectomy edema • Edema following trauma and sports injuries • Reducing wound healing time • Lipedema The AeroDVx Arm system is designed as a wearable compression system, designed to provide mobility for patients

Source page: https://510kreport.com/device/K222823
Methodology: https://510kreport.com/methodology