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510(k) Data Aggregation

    K Number
    K072887
    Device Name
    G-TRAINER MEDICAL
    Manufacturer
    ALTER-G, INC.
    Date Cleared
    2008-01-25

    (107 days)

    Product Code
    BXB
    Regulation Number
    890.5380
    Why did this record match?
    Product Code :

    BXB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alter-G G-Trainer is indicated for use in the following conditions: Aerobic conditioning Weight control and reduction Sport specific conditioning programs Gait training in neurologic patients Strengthening and conditioning in older patients Rehabilitation following injury or surgery of the lower extremity Rehabilitation following injury or surgery of the hip, knee, ankle or foot. Rehabilitation after total joint replacement
    Device Description
    The G-Trainer is designed to provide an adjustable weight support while the user exercises on the incorporated treadmill. The G-trainer is comprised of a standard exercise treadmill with an integrated unweighting component that can effectively reduce the body weight of an individual while they exercise. A bag that looks much like a small tent is placed over the running surface of the treadmill and sealed in such a manner that an electric blower can inflate the bag. The subject wears a special pair of shorts that zip into the top and center of the bag much like the skirt used on a kayak. The subject zips into the bag and stands on the surface of the treadmill. Using a touch screen control panel, the subject is able to increase or decrease the pressure in the bag. The pressure in the bag provides weight support for the user. By this method. the effective weight of the subject on the treadmill surface can be precisely controlled while they exercise. The G-Trainer is comprised of a base frame, a treadmill, an upper support frame, the inflatable bag, a pressure source and regulation system, control electronics and a control console.
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    K Number
    K003272
    Device Name
    FLO-BOOT
    Manufacturer
    DISCOVERY GROUP LLC.
    Date Cleared
    2001-04-04

    (168 days)

    Product Code
    BXB
    Regulation Number
    890.5380
    Why did this record match?
    Product Code :

    BXB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K952975
    Device Name
    ANKLE CALF EXERCISER PHLEBOPUMP
    Manufacturer
    PREVENT PRODUCTS, INC.
    Date Cleared
    1996-09-25

    (456 days)

    Product Code
    BXB
    Regulation Number
    890.5380
    Why did this record match?
    Product Code :

    BXB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACE/PP is intended to exercise the lower leg to help prevent vein thrombosis secondary to venous stasis and blood pooling in the leg. It also retains the exercise function for maintaining muscle tone and preventing stiffness in the ankle joints.
    Device Description
    The ACE/PP is a compact portable exercise device with motor driven foot paddles. The product is controlled by the staff or the patient via an air switch. The paddles are driven in a natural and gentle dorsiflex motion.
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    K Number
    K953456
    Device Name
    E-Z FLEX
    Manufacturer
    FLUID MOTION BIOTECHNOLOGIES, INC.
    Date Cleared
    1996-01-26

    (191 days)

    Product Code
    BXB
    Regulation Number
    890.5380
    Why did this record match?
    Product Code :

    BXB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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