# K122330: Flowtron Foot Garment-Regular-Sterile Flowtron Foot Garment-Large-Sterile

- Pathway: 510(k) (Special)
- Applicant: Arjohuntleigh Polska SP Z.O.O.
- Decided: Dec 7, 2012 after 127 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: 1 generation back to K965153 (1998). 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)
- K965153: Huntleigh FP5000 System Model FP5000, Huntleigh Healthcare, Inc. (1998) Summary page 1.

## Indications for use
Prevention of Deep Vein Thrombosis (DVT) Enhancement of venous & arterial circulation Prevention of venous stasis Assist healing of cutaneous ulcers Reduction of acute or chronic edema Reduction of lower limb pain due to surgery or trauma Reduction of compartmental pressures

Source page: https://510kreport.com/device/K122330
Methodology: https://510kreport.com/methodology