# K012956: Hygia Health Services Reprocessed NU Tech Combo, Model Left Limb and Right Limb

- Pathway: 510(k) (Traditional)
- Applicant: Hygia Health Services, Inc.
- Decided: Apr 11, 2002 after 219 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 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) NuTech® Combination Foot and Calf Wrap: 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
- 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
- K093658: Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical Vasopress Foot Garments (2010), 0 descendants of its own

## Indications for use
The Hygia Health Services Reprocessed NuTech® Combo is used as a non-invasive therapeutic method by patients in the home or institutional setting in order to: e 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

Source page: https://510kreport.com/device/K012956
Methodology: https://510kreport.com/methodology