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510(k) Data Aggregation

    K Number
    K113598
    Device Name
    POWER-LOAD COT FASTENER SYSTEM
    Manufacturer
    STRYKER MEDICAL
    Date Cleared
    2011-12-20

    (15 days)

    Product Code
    FPO, CLA
    Regulation Number
    880.6910
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Power-LOAD™ cot fastening system (model 6390) is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working load of 870 lbs, which includes the weight of the ambulance cot, patient, and equipment attached to the cot (i.e. oxygen bottles, monitors, and/or pumps). The intended users of the device will be trained professionals including: emergency medical service and medical care center personnel, as well as medical first responders, service technicians and installers. The expected service life of the product is 7 years.
    Device Description
    The Power-LOAD system secures an ambulance cot within an emergency transport vehicle/ambulance. Power-LOAD includes a trolley that attaches to the cot during the loading and unloading process, a transfer assembly that facilitates linear motion of the trolley and an anchor assembly that attaches to a floor plate mounted to the vehicle floor. When a Power-LOAD-compatible cot is securely attached to the trolley, a batterypowered hydraulic system assists the operators in lifting, lowering and loading and unloading a cot. When the cot is secured in the transport position, Power-LOAD can interface with and inductively charge compatible model 6506 Power-PRO™ XT and 6516 Power-PROTM IT ambulance cots. In the event of power loss, the system remains functional for securing the cot within the vehicle. In this case, loading and unloading of the cot would be achieved manually, as is standard practice today. There will be three cots compatible with Power-LOAD, Power-PRO XT, Power-PRO IT and Performance-PRO XT.
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    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
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    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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