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510(k) Data Aggregation

    K Number
    K192114
    Device Name
    Game Ready GRPro 2.1 System
    Manufacturer
    Cool Systems, Inc. (dba Game Ready)
    Date Cleared
    2019-10-29

    (84 days)

    Product Code
    IRP, ILO
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cool Systems, Inc. (dba Game Ready)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Game Ready GRPro 2.1 System is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings or home settings.
    Device Description
    The Game Ready GRPro 2.1 System and its accessories including Wraps is a medical device that helps athletes and patients recover from post-surgical and acute injuries to reduce edema, swelling, and pain. The Game Ready GRPro 2.1 System provides cold and compression therapy using ice and water in a portable device. The Game Ready GRPro 2.1 System is a DC-powered, software-controlled device that delivers compressed air and chilled water from the Control Unit through tubing to a Wrap that is designed for a specific body part (e.g., shoulder, elbow, knee, ankle, back) to treat pain and swelling from injuries and/or surgical interventions. The Game Ready GRPro 2.1 System is comprised of the following components: - Control Unit ● - AC Adapter (to convert line power to DC input power) - . Connector Hose (connects Control Unit to the Wrap) - Optional Carry bag ● - Optional Battery Pack (Battery and AC charger) ● - Wrap (Sleeve + Heat Exchanger) ●
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    K Number
    K171685
    Device Name
    Med4 Elite
    Manufacturer
    Cool Systems, Inc. (dba Game Ready)
    Date Cleared
    2017-09-29

    (114 days)

    Product Code
    IRP, ILO
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cool Systems, Inc. (dba Game Ready)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Med4 Elite™ combines cold, heat, contrast and compression therapies. It is intended to treat post-surgical and acute injuries to reduce edema, swelling and pain for which cold and compression are indicated. It is intended to treat post traumatic and/or surgical medical and/or surgical conditions for which localized thermal therapy (hot or cold or contrast) are indicated. It is intended to be used by, or on the order of, licensed healthcare professionals in rehabilitation facilities, outpatient clinics, and athletic training settings.
    Device Description
    The Med4 Elite™ (Model Number 650550) is an AC powered, software-controlled multimodality device, designed to be used in a clinical setting, and under the direction and supervision of a licensed healthcare professional in rehabilitation facilities, outpatient clinics and athletic training settings. The device features iceless cold therapy, heat therapy, contrast (alternating heat and cold) therapy, and intermittent pneumatic compression therapy for one or two patients at a time. The device is designed to be compatible with the pre-existing portfolio of ergonomic Game Ready Wraps made for specific body parts (e.g., shoulder, elbow, knee, ankle, back, etc.). The Wraps are flexible water circulating garments that apply to the body to deliver cold, heat, or rapid contrast temperature and/or compression therapy. The wrap is comprised of an inner ATX Series Heat Exchanger and an Outer Sleeve. The Med4 Elite™ allows for treatment of one or two patients, or two anatomical locations simultaneously. The device is controlled by an intuitive touch screen computer interface, allowing the user to manage the therapy modalities as well as easily adjust and monitor treatment times, temperature and compression settings. The physical description of the Med4 Elite™ is a compact unit with four caster wheels and a built-in handle. It has two separate, covered reservoirs - one for holding cold water and the other for holding hot water. The water reservoirs, pumps, cold engine, valves, power supplies and any other electronics are inside a covered enclosure made out of both plastic and sheet metal that can only be accessed with a tool.
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