510(k) · Cleared

Cleared

Hygia Health Services Reprocessed Nutech Foot Wrap

K012650510(k) TraditionalCleared Apr 12, 2002242-day reviewClass II21 CFR 870.5800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hygia Health Services, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Apr 12, 2002 after a 242-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.

Decided: Apr 12, 2002
Review: 242 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 0

7 later devices descend from it, 3 citing it directly.

This deviceK012650 Hygia Health Services Reprocessed Nutech Foot WrapHygia Health Services, Inc. · 2002
Descendant · cites it directly · 4 of its ownK031559 Renu Medical Reporcessed Compressible Limb SleevesRenu Medical, Inc. · 2003
Descendant · 2 generations on · 2 of its ownK051227 Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1Renu Medical, Inc. · 2006
Descendant · 2 generations on · 0 of its ownK203847 Reprocessed Tri Pulse Compression GarmentRenu Medical, Inc. · 2021
Descendant · cites it directly · 0 of its ownK100969 Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A…Wmi Enterprises, LLC · 2010
Descendant · cites it directly · 0 of its ownK101702 Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2003high 3 (2010) · low 0 (2004)2026

Most influential descendants

Showing 5 of 7 · See all

K031559Renu Medical Reporcessed Compressible Limb SleevesRenu Medical, Inc. · 2003 · cites it directly4descendants
K051227Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1Renu Medical, Inc. · 2006 · 2 generations on2descendants
K203847Reprocessed Tri Pulse Compression GarmentRenu Medical, Inc. · 2021 · 2 generations on0descendants
K100969Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF…Wmi Enterprises, LLC · 2010 · cites it directly0descendants
K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K012650	Hygia Health Services Reprocessed Nutech Foot Wrap	Hygia Health Services, Inc.	2002	—
+1	K031559	Renu Medical Reporcessed Compressible Limb Sleeves	Renu Medical, Inc.	2003	—
+2	K051227	Renu Medical Reprocessed Alp 1 Calf Garment, Model ALP1	Renu Medical, Inc.	2006	—
+2	K203847	Reprocessed Tri Pulse Compression Garment	Renu Medical, Inc.	2021	—
+1	K100969	Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A, T-2000B…	Wmi Enterprises, LLC	2010	—
+1	K101702	Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs	Midwest Reprocessing Center, LLC	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2006	1	0
2008	1	0
2010	3	0
2021	1	0

FIG. 1 — Lineage of K012650, 2002–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JOW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JOW device

#1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	—	NuTech® PlexiPulse Foot Wrap Named without a submission number			—

What descends from it? (7)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K031559	Renu Medical Reporcessed Compressible Limb Sleeves	Renu Medical, Inc.	2003	4
K100969	Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF…	Wmi Enterprises, LLC	2010	0
K101702	Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot Cuffs	Midwest Reprocessing Center, LLC	2010	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K031559 (Renu Medical, Inc., 2003) has gone furthest, with 4 descendants of its own.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOW

7in 2025

2007high 18 (2010) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOW

168in 2025

2007high 252 (2026) · low 63 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JOW

1in 2019

2007high 7 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JOW

24in 2025

2007high 169 (2013) · low 12 (2007)2025

MAUDE reports naming product code JOW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	66	0	12
2008	4	112	7	36
2009	3	84	0	45
2010	18	71	2	66
2011	11	104	3	50
2012	13	63	2	100
2013	17	94	0	169
2014	16	91	0	93
2015	10	160	0	137
2016	9	121	0	150
2017	9	116	1	149
2018	11	136	0	114
2019	11	88	1	102
2020	14	158	0	50
2021	16	132	0	34
2022	7	80	0	27
2023	6	160	0	57
2024	8	197	0	30
2025	7	168	0	24
2026	6	252	0	—

What is it indicated for?

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

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012650 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012650: Hygia Health Services Reprocessed Nutech Foot Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012650

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026