# K101702: Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs

- Pathway: 510(k) (Traditional)
- Applicant: Midwest Reprocessing Center, LLC
- Decided: Aug 27, 2010 after 71 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: 4 generations back to K881632 (1988). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090074: Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs, Hygia Health Services, Inc. (2009) Summary page 1.
- K012956: Hygia Health Services Reprocessed NU Tech Combo, Model Left Limb and Right Limb, Hygia Health Services, Inc. (2002) Summary page 1.
- K012657: Hygia Health Services Reprocessed Nutech Calf Wrap, 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 1.
- K012651: Hygia Health Services Reprocessed Huntleigh Foot Wrap Models FG 100, FG 200, Hygia Health Services, Inc. (2002) Summary page 1.
- K012650: Hygia Health Services Reprocessed Nutech Foot Wrap, Hygia Health Services, Inc. (2002) Summary page 1.
- 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.
- 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.
- K881632: Flowtron DVT System AC500 Pump, L501 Garment, Huntleigh Technology, Inc. (1988)
- K981311: Cowboy XV, Kci New Technologies, Inc. (1999)
- K944567: Cowboy X, Kinetic Concepts, Inc. (1995) Summary page 1.

## Indications for use
The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are used in the treatment of venous leg ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Venodyne Sleeves are also a non-invasive therapeutic method for prevention of deep vein thrombosis. The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are used in the treatment of venous leg / foot ulcers and edema which are disorders associated with venous insufficiency. The Midwest Reprocessing Center Reprocessed Venodyne Foot Cuffs are also a non-invasive therapeutic method for prevention of deep vein thrombosis. The Midwest Reprocessing Center 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 Midwe st Reprocessing Center Reprocessed NuTech® Combo is used-as a non-invasive therapeutic method by patients in the home or institutional setting in order 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 The Midwest Reprocessing Center Reprocessed NulechO Calf Wrap is used as a non-invasive therapeutic method to be used by patients in the home or institutional setting in order 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 The Midwest Reprocessing Center Reprocessed Nulech® Foot Wrap is designed to enhance circulation of blood in the venules and arterioles. It 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 The Midwest Reprocessing Center Reprocessed Huntleigh Flowtrong) Single Pulse DVT Sleeve is 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 Midwest Reprocessing Center 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/K101702
Methodology: https://510kreport.com/methodology