510(k) · Cleared

Cleared

Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N

K100969510(k) TraditionalCleared Sep 20, 2010165-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

Wmi Enterprises, LLC · JOW Sleeve, Limb, Compressible

Cleared on Sep 20, 2010 as substantially equivalent to K061866 (Thermotek, Inc., 2006) and 4 other predicates after a 165-day review. Its family tree reaches back 3 generations to 1992.

Decided: Sep 20, 2010
Review: 165 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 5

Its longest line of descent runs back 3 generations to K915638 (1992). 16 ancestors in all, the oldest K881632 (1988). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK915638 Talley TM200 Intermttent Compression UnitProgressive Medical Technology, Inc. · 1992
2 generations backK022340 Travelair Portable Compression SystemDynamic Air, Inc. · 2003
1 generation backK061125 Dvtcare CA5Doctors Orders · 2006
This deviceK100969 Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A…Wmi Enterprises, LLC · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K915638	Talley TM200 Intermttent Compression Unit	Progressive Medical Technology, Inc.	1992	—
−2	K022340	Travelair Portable Compression System	Dynamic Air, Inc.	2003	—
−1	K061125	Dvtcare CA5	Doctors Orders	2006	—
0 (this device)	K100969	Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A, T-2000B…	Wmi Enterprises, LLC	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1995	2	0
1996	1	0
1997	1	0
1999	1	0
2000	1	0
2001	1	0
2002	2	0
2003	1	0
2005	1	0
2006	1	0

FIG. 1 — Lineage of K100969, 1992–2010Source: 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? (5)

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
*	K061866	Nanotherm, Vascutherm and Prothermo Therapy Wraps Summary page 1 …ion of the following predicate devices, and do not raise any new questions of safety or effectiveness. * ThermoTek, Inc. NanoTherm and VascuTherm K06 1866 * Aircast VenaFlow system Disposable Cuffs K023 800 * Doctor's Orders, Inc. DVTcare CA5…	Thermotek, Inc.	2006	—
*	K023800	Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017 Summary page 1 …f safety or effectiveness. * ThermoTek, Inc. NanoTherm and VascuTherm K06 1866 * Aircast VenaFlow system Disposable Cuffs K023 800 * Doctor's Orders, Inc. DVTcare CA5 K061 125 * Hygia Health Services, Inc. NuTech Foot Wrap…	Aircast, Inc.	2003	—
*	K061125	Dvtcare CA5 Summary page 1 …K06 1866 * Aircast VenaFlow system Disposable Cuffs K023 800 * Doctor's Orders, Inc. DVTcare CA5 K061 125 * Hygia Health Services, Inc. NuTech Foot Wrap K012650 * Huntleigh Flowtron Excel…	Doctors Orders	2006	—
*	K012650	Hygia Health Services Reprocessed Nutech Foot Wrap Summary page 1 …K023 800 * Doctor's Orders, Inc. DVTcare CA5 K061 125 * Hygia Health Services, Inc. NuTech Foot Wrap K012650 * Huntleigh Flowtron Excel K88 1632 Indications for Use Indications For Use:…	Hygia Health Services, Inc.	2002	—
*	K881632	Flowtron DVT System AC500 Pump, L501 Garment Summary page 1 …K061 125 * Hygia Health Services, Inc. NuTech Foot Wrap K012650 * Huntleigh Flowtron Excel K88 1632 Indications for Use Indications For Use:…	Huntleigh Technology, Inc.	1988	—

Also cleared against K061866: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
2 of the 16 ancestors have a recall of any class.
8 other devices also cite its predicate K061866.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

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?

* Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedemna; * Reduction of edema associated with soft tissue injuries such as ligament sprains, postoperative edema, and bums; * Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions; * Decrease the risk of deep venous…

Read the full statement (161 words)

* Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedemna;

* Reduction of edema associated with soft tissue injuries such as ligament sprains, postoperative edema, and bums;

* Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions;

* Decrease the risk of deep venous thrombosis (DVT);

* Aids the blood flow back to the heart;

* Treat and assist healing of cutaneous ulceration (wounds), reduce wound healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.

o Primary lymphedema (for example congenital/Milroy's Disease)

o Secondary lymphedema (for example post-mastectomy, chronic edema, post-traumatic edema)

o Venous disorders (for example venous insufficiency, varicose veins, venous stasis ulcers)

o Dysfunction of the muscle pump (for example promotion of wound recovery, reduction of edema and lower limb pain following trauma and sports injuries)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100969 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100969: Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100969

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026