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510(k) Data Aggregation

    K Number
    K041336
    Device Name
    PRO WALKER PL-200 POWER WHEELCHAIR
    Manufacturer
    PRO WALKER INC.
    Date Cleared
    2004-07-20

    (62 days)

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

    PRO WALKER INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The PRO WALKER Power Wheelchair, PL-200 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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    K Number
    K041337
    Device Name
    PRO WALKER ML-300 FOLDABLE WHEELCHAIR
    Manufacturer
    PRO WALKER INC.
    Date Cleared
    2004-05-28

    (9 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRO WALKER INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The PRO WALKER ML-300 Foldable Wheelchair is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
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