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510(k) Data Aggregation

    K Number
    K020592
    Device Name
    ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001
    Manufacturer
    ALBA-WALDENSIAN, INC.
    Date Cleared
    2002-04-03

    (40 days)

    Product Code
    DWL
    Regulation Number
    880.5780
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALBA-WALDENSIAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To assist in limb size maintenance of patients with mild to moderate edema or lymphedema of the arm.
    Device Description
    The C.A.L.M. Sleeve is of circular knit construction, and is constructed from Nylon and Spandex yarns. The sleeve is intended to be worn on the arm, and covers the arm from wrist to 2" below the pivot point of the shoulder. The C.A.L.M. Sleeve is non-sterile, and is not intended to be sterilized in use. The knit of the sleeve is graduated. The length of yarn knit in gradually increases from the wrist to the upper portion of the sleeve. This results in a sleeve with compression that decreases from the wrist to the upper arm portion of the sleeve. The C.A.L.M. Sleeve yields 20 to 30 mmHg (millimeters Mercury) compression to the wrist area, with gradually decreasing compression through the upper arm.
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    K Number
    K961405
    Device Name
    ALBA HEALTH PAS WRAP SYSTEM
    Manufacturer
    ALBA-WALDENSIAN, INC.
    Date Cleared
    1996-12-26

    (259 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALBA-WALDENSIAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indications for use and the contraindication are listed separately in this application.
    Device Description
    The PAS Wrap System is composed of two leg wrap members constructed of an inflatable bladder enclosed in a fabric cover with an outside surface that will accept a Velcro fastener hook strip. Extending from one side of this enclosed bladder is an elastic fabric cut to conform to the shape of the calf area of the leg. This fabric is wrapped around the back of the calf and is attached to the other side of the bladder with a Velcro fastener. The Velcro fastener allows for a tight fit on various size legs. The inflation pump is attached to the bladders and is energized. The bladder on each leg is alternately inflated and deflated to yield approximately 65mm Hg pressure on the calf area of the leg. This pressure causes pooled blood to be expelled from the calf and to proceed toward the heart. This helps to prevent embolisms from forming in the calf area.
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