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510(k) Data Aggregation

    K Number
    K092225
    Device Name
    AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR
    Manufacturer
    AMYLIOR, INC.
    Date Cleared
    2009-10-09

    (78 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMYLIOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AMYPOWER ALLTRACK power wheelchair's intended use is to provide mobility to persons limited to a seating position, that have the capability of operating a powered wheelchair. The AMYPOWER ALL TRACK power wheelchair empowers physically challenged individuals by providing a means of mobility.
    Device Description
    The AMYPOWER ALLTRACK power wheelchair is a battery powered, motor driven device. It is a rigid or "non-folding" type power wheelchair design that offers functionality to be used as a mid wheel drive or a rear wheel drive base. The design offers a modular approach and can be configured in multiple versions to suit different client needs. The ALLTRACK series power wheelchair is designed to offer the ultimate in safety, stability, performance and comfort for the user. It features an active six wheel suspension as well as a seat suspension, and front and rear anti-tip casters which allow for surface contact of all six wheels at all times and prevents pitching on slopped terrain. The ALLTRACK power wheelchair utilizes components typically found on most wheelchairs, including but not limited to a rigid steel frame, a seat, armrests, front riggings, two main drive wheels, two electric drive motors, front & rear castors, two batteries, a charger, a positioning belt and a controller.
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    K Number
    K994072
    Device Name
    AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM
    Manufacturer
    AMYLIOR, INC.
    Date Cleared
    2000-01-13

    (42 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMYLIOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the device is to provide posterior tilting for positioning and pressure relief in a powered wheelchair.
    Device Description
    AmySystems PTS50CG Weight Shift Power Tilt System
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    K Number
    K994107
    Device Name
    AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS.
    Manufacturer
    AMYLIOR, INC.
    Date Cleared
    2000-01-13

    (38 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMYLIOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the device is to provide posterior tilting for positioning and pressure relief in a powered wheelchair.
    Device Description
    Not Found
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