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510(k) Data Aggregation
K Number
K101035Device Name
WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000
Manufacturer
Date Cleared
2010-10-29
(198 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
WMI ENTERPRISES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K100969Device Name
WMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000N
Manufacturer
Date Cleared
2010-09-20
(165 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
WMI ENTERPRISES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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 lymphedema:
- Reduction of edema associated with soft tissue injuries such as ligament sprains, postoperative edema, and burns;
- 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.
- Primary lymphedema (for example congenital/Milroy's Disease)
- Secondary lymphedema (for example post-mastectomy, chronic edema, post o traumatic edema)
- Venous disorders (for example venous insufficiency, varicose veins, venous stasis o ulcers)
- Dysfunction of the muscle pump (for example promotion of wound recovery, o reduction of edema and lower limb pain following trauma and sports injuries)
Device Description
The cuffs contain interconnected, segmented inflatable chambers constructed of latex-free brushed nylon with polyester foam backing and an internal coating of latex free polymer that creates an airtight seal. The inner lining is elastic, which allows for the inflation. The bladder is constructed of polyvinyl chloride (PVC), RF welded at the seams. The inflation/deflation tubes are also composed of PVC. The hook fasteners are made of polyethylene.
These are pneumatically controlled cuffs, actuated by an electronic pump unit and are designed for singleuse. Inflation of the garment is accomplished using air or water and a controller cycle that functions to alternately inflate and deflate the cuffs in a predetermined manner and interval. The garments have only been tested to be used with the ThermoTek, Inc. NanoTherm and VascuTherm pneumatic pumps. Air/water is delivered to the cuff through flexible plastic tubing, inflating it to a specified pressure, to compress the affected anatomical part, thus aiding venous return. Air/water pressure and delivery are monitored by elements within the pump unit. Immediately after the pump element detects that the cuff has achieved the current set pressure, the cuff deflates to ambient pressure, allowing the veins to refill bringing oxygenated blood back to the area. The process essentially simulates muscle contractions in the body area, facilitating appropriate venous flow. The foot cuff simulation. The cycle continues until the unit is turned off.
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