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510(k) Data Aggregation

    K Number
    K072620
    Device Name
    GAME READY CLASSIC SYSTEM, MODEL 550550
    Manufacturer
    COOLSYSTEMS, INC.
    Date Cleared
    2007-10-31

    (44 days)

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

    COOLSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Game Ready Classic 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 Classic System is comprised of the following components: - Control Unit, with AC Adapter (to convert line power to DC input power) . - . Connector Hose (connects Control Unit to Wrap) - Wrap (Heat Exchanger + Sleeve) ● - Optional Carry Bag . - Optional Battery Pack (under development) . The Game Ready Classic System is a DC-powered device that provides intermittent compression and controlled cold therapy by controlling fluid flow and air pressure through a Wrap that is specially designed for a specific body part or location (e.g., shoulder, elbow, knee, ankle, back). A Wrap is comprised of a Sleeve (the outer covering for the Heat Exchanger) and a Heat Exchanger. Cooling is provided by circulating ice water from the Control Unit through the Connector Hose to the Wrap. Compression is provided by an intermittent-cycling pneumatic pump that pumps air from the Control Unit through the Connector Hose to the Wrap. The user can adjust the amount of compression, the amount of cooling, and the treatment time. The Control Unit software is designed to protect both the user and the Control Unit from harm by shutting off the system and sounding an alarm if there is insufficient fluid flow or in case of an over-pressure or under-pressure situation. The software detects other, less-serious error conditions and sounds a warning beep to alert the user, so that the error condition can be corrected. These protections have been carried forward from the original Game Ready to Game Ready Classic.
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    K Number
    K071050
    Device Name
    GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM
    Manufacturer
    COOLSYSTEMS, INC.
    Date Cleared
    2007-06-29

    (77 days)

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

    COOLSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Game Ready System combines cold and compression therapies. It is intended to treat post-surgical 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 healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.
    Device Description
    The Game Ready System is comprised of the following components: Control Unit, with AC Adapter (to convert line power to DC input power), Connector Hose (connects Control Unit to Wrap), Wrap (Heat Exchanger + Sleeve), Optional Carry Bag, Optional Battery Pack. The Game Ready System is a DC-powered device that provides intermittent compression and controlled cold therapy by controlling fluid flow and air pressure through a Wrap that is specially designed for a specific body part or location (e.g., shoulder, elbow, knee, ankle, back). A Wrap is comprised of a Sleeve (the outer covering for the Heat Exchanger) and a Heat Exchanger. Cooling is provided by circulating ice water from the Control Unit through the Connector Hose to the Wrap. Compression is provided by an intermittent-cycling pneumatic pump that pumps air from the Control Unit through the Connector Hose to the Wrap. The user can adjust the amount of compression, the amount of cooling, and the treatment time. The Control Unit software is designed to protect both the user and the Control Unit from harm by shutting off the system and sounding an alarm if there is insufficient fluid flow or in case of an over-pressure or under-pressure situation. The software detects other. less-serious error conditions and sounds a warning beep to alert the user, so that the error condition can be corrected. The Game Ready System is available in two configurations: the Game Ready Professional Therapy System (P/N 550100) and the Pre-Programmed Game Ready Professional Therapy System (P/N 550350)
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