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510(k) Data Aggregation

    K Number
    K072598
    Device Name
    IRSG I-MOVER FOR BEDS
    Manufacturer
    INTERNATIONAL RETAIL SERVICES GROUP, LLC
    Date Cleared
    2008-04-14

    (213 days)

    Product Code
    FPO
    Regulation Number
    880.6910
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL RETAIL SERVICES GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The bed mover is intended to assist a single operator in the moving of wheeled beds and stretchers from one location to another within a healthcare facility. Examples of usage include: - a single operator may move empty beds to staging or storage areas within the healthcare facility. - a single operator may move patient-laden beds from one location to another within the healthcare facility.
    Device Description
    The IRSG i-mover for beds is a battery-powered, temporary accessory to most wheeled hospitals beds and stretchers. It is unit operated by a single caregiver to assist in the movement of most wheeled hospital beds and stretchers commonly used within a healthcare facility. Only the caregiver, not the patient, can control this powered assistive device. This device is not permanently attached to or made a part of the stretcher or bed. The FDA has classified this device as an accessory to the wheeled bed or stretcher which the device will assist in moving. These beds and stretchers are Class I (hydraulic or manual beds) and Class II (powered adjustable beds and wheeled stretchers). The FDA has classified this device as a Class I device when used with non-patient laden beds and a Class II device when assisting in movement of a patient-laden bed.
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