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510(k) Data Aggregation

    K Number
    K073013
    Device Name
    CTU676 DEVICE
    Date Cleared
    2007-11-21

    (27 days)

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

    COMPRESSION TECHNOLOGIES UNLIMITED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CTU676 is a prescriptive device that includes continuous enhanced circulation therapy of the lower limbs. The CTU676 is intended for use in the following: - Enhancing blood circulation . - Reducing wound-healing time. - Preventing Deep Vein Thrombosis (DVT). - Diminishing post-operative pain and swelling . - Treatment and assistance in healing: stasis dermatitis ◆ - . Venous stasis ulcers; arterial and diabetic ulcers - Treatment of Chronic venous insufficiency . - Reducing edema .
    Device Description
    The CTU676 devices are used for different forms of compression therapy. The system is an air inflatable garment that is controlled by an electrical air pump. The air pump controls the garment so chambers inflate and deflate sequentially over a period of ~ 85 seconds. Patient or staff operated controls with visual and / or audible alarms for low pressure, high pressure, low battery, and system failures. The controls use a power on/off switch on the side of the unit. On the front of the unit are fault indicators. The preset to 52 mmHg. The power on light will flash and stay illuminated when the unit is operating. The charging light will illuminate when batteries are charging.
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