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510(k) Data Aggregation

    K Number
    K232270
    Device Name
    DVT Motion Pneumatic Compression Device
    Manufacturer
    Koge Micro Tech Co., Ltd.
    Date Cleared
    2024-03-06

    (219 days)

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

    Koge Micro Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DVT Motion Pneumatic Compression Device is a prescription device intended for prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in the prevention of venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital setting.
    Device Description
    The DVT Motion Pneumatic Compression Device is a portable, rechargeable battery-powered device intended for prescribed home use or hospital use to help prevent Deep Vein Thrombosis (DVT) in patients by stimulating blood flow. This is accomplished using an electronically controlled pump delivering a set amount of air to the leg garment that compresses the calf and aids blood flow through the lower extremities. The pump will inflate to a preset pressure of 50mmHg and deflate once this pressure is reached. The cycle continues until the unit is turned off. The tube free solution comes complete with a fully integrated lithium ion battery that supplies over 18 hours of treatment on a single charge, assuring that patients can be transported easily from the hospital to their homes without interruptions in treatment.
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