# K012651: Hygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100, FG 200

- Pathway: 510(k) (Traditional)
- Applicant: Hygia Health Services, Inc.
- Decided: Apr 12, 2002 after 242 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
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Huntleigh Foot Wrap Garment: named in the summary without a submission number

## Most influential descendants
- K031559: Renu Medical Reporcessed Compressible Limb Sleeves (2003), 4 descendants of its own
- K051227: Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1 (2006), 2 descendants of its own
- K090074: Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs (2009), 1 descendant of its own
- K203847: Reprocessed Tri Pulse Compression Garment (2021), 0 descendants of its own
- K101702: Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs (2010), 0 descendants of its own

## Indications for use
The Hygia Health Services Reprocessed Huntleigh Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It is to be used by patient’s in both the home and institutional settings as a non-invasive therapeutic method to prevent: Deep vein thrombosis Reduce wound healing time Treat and assist healing of venous leg ulcers Reduce edema caused by venous insufficiency in the lower extremities Decrease compartmental pressures

Source page: https://510kreport.com/device/K012651
Methodology: https://510kreport.com/methodology