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510(k) Data Aggregation

    K Number
    K070324
    Device Name
    IPC-BOOT
    Manufacturer
    C-BOOT LTD.
    Date Cleared
    2007-05-03

    (87 days)

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

    C-BOOT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IPC-Boot is a prescriptive device that induces controlled compression of the calf, the foot or a combined compression of both. The IPC-Boot is intended to assist patients, suffering from lymphatic or venous disorders, by treating many conditions including: Prevention of deep vein thrombosis (DVT), Enhancement of blood circulation, Reduction of post-operative pain and swelling, Reduction of wound-healing time, Stasis dermatitis, Treatment and assist healing of cutaneous ulceration, Venous stasis ulcers, Leg ulcers, Chronic venous insufficiencies, Reduction of edema, Prevent pooling of fluids in limbs, Lymphedema
    Device Description
    IPC-Boot is actually a very similar version of C-Boot's legally marketed device, cleared under 510(k) number K041659. Similarly to the legally marketed device, it is made of the same materials and has the same design, technology and performances. The only modification that was made to the predicate device is the addition of external electric pump that can activate the device electrically when the patient is immobile. This modification provides a solution for such patients. The patient may choose whether the device will be used mechanically (self powered), by walking (as the original device) or electrically as the modified new device: IPC-Boot, when patient is immobile. The IPC-Boot is a wearable pneumatic compression technology embodied in a therapeutic boot that has the potential to increase treatment efficacy and improve the quality of life for peripheral vascular and lymph disorders patients. The IPC-Boot contains boot legging with inflatable sleeves from the patient's foot up to the knee. The IPC-Boot uses an external electric pump. The pump is generated the air to inflate the sleeves through the control system for producing intermittent compression to the lower limb. C-Boot's solution integrates the technological advantages of dynamic compression pumps that enable preset sequential pressure control which is identical to the pressure level of the preamended device (predicate). This enables the patient to individualize treatment regimes, with the mobility benefit of static compression stockings that activate the calf muscle pump and strengthened the body's natural tendency to enhance lymphatic and venous return, The modified device covers both self-powered and electrical compression devices and creates one integrated device.
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    K Number
    K041659
    Device Name
    C-BOOT
    Manufacturer
    C-BOOT LTD.
    Date Cleared
    2004-10-28

    (132 days)

    Product Code
    JOW, 870
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    C-BOOT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C-Boot™ is a prescriptive device that induces controlled compression of the calf, the foot or a combined compression of both. The C-Boot™ is intended to assist patients, suffering from lymphatic or venous disorders, by treating many conditions including: - Prevention of deep vein thrombosis (DVT) - Enhancement of blood circulation - Reduction of post-operative pain and swelling - Reduction of wound-healing time - Stasis dermatitis - Treatment and assist healing of cutaneous ulceration - Venous stasis ulcers - Leg ulcers - Chronic venous insufficiencies - Reduction of edema - Prevent pooling of fluids in limbs - Lymphedema
    Device Description
    C-Boot Ltd. introduces a wearable pneumatic compression technology embodied in a therapeutic boot that has the potential to increase treatment efficacy and improve the quality of life for peripheral vascular and lymph distorders patients. C-Boot's solution integrates the technological advantages of dynamic compression pumps, that enable preset sequential pressure control to individualize treatment regimes, with the mobility benefit of static compression stockings, that activate the calf muscle pump and strengthened the body's natural tendency to enhance lymphatic and venous return. The device relates to a self-powered compression devices and methods for promoting circulation and therapeutic compression: It is comprising a pump, a plurality of sleeves or limb massager, which utilizes sequential, cyclical pressure, energy or vector forces, to aid circulation in a body part such as the limbs. The inflatable sleeves are filled with air by the pump and transmit massaging movement to the vessel walls whenever the patient wearing the device - walks or transmits body's weight from one leg to another. The pressure generated is a function of the user's body weight and gravitational force. The device provides methods to harness energy generated during movement and weight transfer and uses the energy for compressing to create a massaging effect on the circulation and the muscular-skeletal system.
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