# K090074: Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs

- Pathway: 510(k) (Traditional)
- Applicant: Hygia Health Services, Inc.
- Decided: Apr 22, 2009 after 100 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: 3 generations back to K881632 (1988). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061967: SCD Garment, Model VP530, Compression Therapy Concepts, Inc. (2006) Summary page 1.
- K061814: Vasopress DVT System, Model VP500D, Compression Therapy Concepts, Inc. (2006) Summary page 1.
- K000147: CTC DVT-1 Calf Garment, Model DVT-1, Compression Therapy Concepts, Inc. (2000) Summary page 1.
- K022786: DVT60, Huntleigh Healthcare, Inc. (2002) Summary page 1.
- K010744: Flowtron Universal, Model AC600, Huntleigh Healthcare, Inc. (2002) Summary page 1.
- K974318: Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments for the Limb, Healthcare Service and Supply (1998) Summary page 1.
- K011318: Venodyne DVT Advantage Plus, Microtek Medical, Inc. (2001) Summary page 1.
- K001802: Venodyne DVT Advantage Model 610, Microtek Medical, Inc. (2001) Summary page 1.
- K930526: Intermittent Compression System Model 5000, Advanced Instruments, Inc. (1993) Summary page 1.
- K053575: Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs, Hygia Health Services, Inc. (2006) Summary page 2.
- K012417: Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329, 5330, 5345, 5480, Hygia Health Services, Inc. (2002) Summary page 2.
- K012654: Hygia Health Services Reprocessed Huntleigh Flowtron DVT Sleeve Models DVT10, DVT 20, DVT 30, DVT 40, Hygia Health Services, Inc. (2002) Summary page 2.
- K012651: Hygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100, FG 200, Hygia Health Services, Inc. (2002) Summary page 2.

## Most influential descendants
- K101702: Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs (2010), 0 descendants of its own

## Indications for use
The Hygia Health Services Reprocessed Venodyne Sleeves are used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency. The Hygia Health Services Reprocessed Venodyne Sleeves are also a non-invasive therapeutic method for prevention of deep vein thrombosis. The Hygia Health Services Reprocessed CTC VasoPress Compression Sleeves are used as a non-invasive therapeutic method to prevent deep vein thrombosis, and treat venous leg ulcers and edema that result from venous insufficiency. The Hygzia Health Services Reprocessed Venodyne Foot Cuffs are used in the treatment of venous leg I foot ulcers and edema which are disorders associated with venous insufficiency. The Hygia Health Services Reprocessed Venodyne Foot Cuffs are also a non-invasive therapeutic method for prevention of deep vein thrombosis.

Source page: https://510kreport.com/device/K090074
Methodology: https://510kreport.com/methodology