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510(k) Data Aggregation

    K Number
    K020001
    Device Name
    PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3
    Manufacturer
    TRANSWORLD MOBILITY DISTRIBUTION, L.L.C.
    Date Cleared
    2002-03-21

    (78 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANSWORLD MOBILITY DISTRIBUTION, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the PF-3 is to provide mobility to adults with the ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.
    Device Description
    Model PF-3, Four Wheel Electric Scooter
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    K Number
    K020002
    Device Name
    MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33
    Manufacturer
    TRANSWORLD MOBILITY DISTRIBUTION, L.L.C.
    Date Cleared
    2002-03-21

    (78 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANSWORLD MOBILITY DISTRIBUTION, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the P-33 is to provide mobility to adults with the capacity to maintain a seated position on the scooter and have the capacity to operate a simple hand control.
    Device Description
    Model P-33, Three Wheel Electric Scooter
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    K Number
    K011745
    Device Name
    HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR
    Manufacturer
    TRANSWORLD MOBILITY DISTRIBUTION, L.L.C.
    Date Cleared
    2001-08-30

    (85 days)

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

    TRANSWORLD MOBILITY DISTRIBUTION, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the HP-3 is to provide mobility to adults limited to a sitting position that have the capacity to operate a simple hand control.
    Device Description
    Model HP-3, Power Wheelchair
    Ask a Question
    K Number
    K011744
    Device Name
    HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR
    Manufacturer
    TRANSWORLD MOBILITY DISTRIBUTION, L.L.C.
    Date Cleared
    2001-08-24

    (80 days)

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

    TRANSWORLD MOBILITY DISTRIBUTION, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the HP-5 is to provide mobility to adults limited to a sitting position that have the capacity to operate a simple hand control and also allow this chair to fold for easy transportation.
    Device Description
    Model HP-5, Power Wheelchair
    Ask a Question

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