# K053575: Hygia Health Services Reprocessed Kendall SCD Express Sleeves/Foot Cuffs

- Pathway: 510(k) (Traditional)
- Applicant: Hygia Health Services, Inc.
- Decided: Feb 15, 2006 after 55 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 K881632 (1988). 12 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040511: SCD Express Portable Compression System, Tyco Healthcare/Kendall (2004) Summary page 1.
- K040649: Kendall SCD Express Kambia Thigh Length Tearaway Sleeve, Tyco Healthcare (2004) 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.
- K992454: Venaflow System, Model 30A, Aircast, Inc. (2000) Summary page 1.
- K012417: Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329, 5330, 5345, 5480, Hygia Health Services, Inc. (2002) Summary page 1.
- 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.
- K021509: Hygia Health Services Reprocessed Novamedix Impab Models 5065, 5075, 5087, 5089, Hygia Health Services, Inc. (2002) Summary page 2.

## Most influential descendants
- K090074: Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs (2009), 1 descendant of its own
- K101330: Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest Reprocessing Center Reprocessed Alp Sle (2010), 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 Aircast Sleeves/Foot Cuffs are used in the treatment of venous leg/foot ulcers and edema which are disorders associated with venous insufficiency. The Hygia Health Services Reprocessed Aircast Sleeves/Foot Cuffs are also a non-invasive therapeutic method for prevention of deep vein thrombosis.

Source page: https://510kreport.com/device/K053575
Methodology: https://510kreport.com/methodology