# K133119: Flowtron ACS800 Pump and Tri Pulse Garments

- Pathway: 510(k) (Traditional)
- Applicant: Arjohuntleigh Polska SP Z.O.O.
- Decided: Feb 28, 2014 after 151 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: 2 generations back to K890938 (1989). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010744: Flowtron Universal, Model AC600, Huntleigh Healthcare, Inc. (2002) Summary page 1.
- K012008: STS Range , Models STS20,STS30,STS40, Huntleigh Healthcare, Inc. (2001) Summary page 1.

## Most influential descendants
- K143438: Flowtron ACS900 (2015), 1 descendant of its own
- K191937: Ezvena IPC, Ezvena SQS (2020), 0 descendants of its own

## Indications for use
To help prevent Deep Vein Thrombosis (DVT)

Source page: https://510kreport.com/device/K133119
Methodology: https://510kreport.com/methodology