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510(k) Data Aggregation

    K Number
    K193079
    Device Name
    ICE COMPRESSION FIRST, DUO, & MOOVE Systems
    Manufacturer
    Date Cleared
    2021-01-11

    (433 days)

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

    mks paris

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ICE COMPRESSION FIRST, DUO, and MOOVE Systems combine cold and compression therapies. They are intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. They are intended to be used by or on the order of licensed healthcare professionals in hospital, outpatient clinics, athletic training settings, or home settings.
    Device Description
    The ICE COMPRESSION FIRST, DUO, & MOOVE System and its accessories, including the Splints, is designed to treat post-surgical and acute injuries to reduce edema, swelling, and pain when cold and compression are indicated. The ICE COMPRESSION System provides cold and compression therapy using ice and water. The ICE COMPRESSION System is a DC-powered, software-controlled device that delivers compressed air and chilled water from the Control Module through tubing to a Splint that is designed for a specific body part (e.g., shoulder, wrist, knee, leg, hip and ankle, back) to treat pain and swelling from injuries and/or surgical interventions.
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