# K031559: Renu Medical Reporcessed Compressible Limb Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: Renu Medical, Inc.
- Decided: Nov 12, 2003 after 177 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 K012417 (2002). 7 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021509: Hygia Health Services Reprocessed Novamedix Impab Models 5065, 5075, 5087, 5089, 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.
- K012657: Hygia Health Services Reprocessed Nutech Calf Wrap, Hygia Health Services, Inc. (2002) Summary page 3.
- K012956: Hygia Health Services Reprocessed NU Tech Combo, Model Left Limb and Right Limb, Hygia Health Services, Inc. (2002) Summary page 3.
- K012650: Hygia Health Services Reprocessed Nutech Foot Wrap, Hygia Health Services, Inc. (2002) Summary page 3.
- K012417: Hygia Health Service Reprocessed Kendall SCD Sleeve, Models # 5329, 5330, 5345, 5480, Hygia Health Services, Inc. (2002) Summary page 4.
- (no number) Novamedix ImPad® A-V Impulse System Rigid Sole Foot Cover: named in the summary without a submission number
- (no number) Huntleigh DVT Compression Sleeves: named in the summary without a submission number
- (no number) Huntleigh Foot Wrap: named in the summary without a submission number
- (no number) NuTech Calf Wrap: named in the summary without a submission number
- (no number) NuTech Combo: named in the summary without a submission number
- (no number) NuTech Plexipulse System: named in the summary without a submission number
- (no number) Kendall SCD: named in the summary without a submission number
- (no number) Microtek Medical Venodyne Sleeve: named in the summary without a submission number

## Most influential descendants
- K051227: Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1 (2006), 2 descendants of its own
- K203847: Reprocessed Tri Pulse Compression Garment (2021), 0 descendants of its own
- K093658: Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical Vasopress Foot Garments (2010), 0 descendants of its own
- K080551: University Health Care Processed Alternating Leg Pressure (Uhc Apl) Sleeve Device (2008), 0 descendants of its own

## Indications for use
The Hygia West Reprocessed Huntleigh DVT Sleeve is to be used by patients in both the home and institutional settings used as a non-invasive therapeutic method to: • Prevent deep vein thrombosis and resulting pulmonary embolism • Intra-operative compression therapy

Source page: https://510kreport.com/device/K031559
Methodology: https://510kreport.com/methodology