# K100969: Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N

- Pathway: 510(k) (Traditional)
- Applicant: Wmi Enterprises, LLC
- Decided: Sep 20, 2010 after 165 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: 3 generations back to K915638 (1992). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061866: Nanotherm,  Vascutherm and Prothermo Therapy Wraps, Thermotek, Inc. (2006) Summary page 1.
- K023800: Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017, Aircast, Inc. (2003) Summary page 1.
- K061125: Dvtcare CA5, Doctors Orders (2006) Summary page 1.
- K012650: Hygia Health Services Reprocessed Nutech Foot Wrap, Hygia Health Services, Inc. (2002) Summary page 1.
- K881632: Flowtron DVT System AC500 Pump, L501 Garment, Huntleigh Technology, Inc. (1988) Summary page 1.

## Indications for use
* 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)

Source page: https://510kreport.com/device/K100969
Methodology: https://510kreport.com/methodology