# K012650: Hygia Health Services Reprocessed Nutech Foot Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Hygia Health Services, Inc.
- Decided: Apr 12, 2002 after 242 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.
7 later devices descend from it; 3 cite it directly.
0 of 8 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® PlexiPulse Foot 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
- K100969: Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N (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 NuTech® 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

Source page: https://510kreport.com/device/K012650
Methodology: https://510kreport.com/methodology