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    FDA 510(k) FDA class 1 Substantially Equivalent 🇹🇼 Taiwan

    PRO WALKER ML-300 FOLDABLE WHEELCHAIR

    K Number: K041337 · Decision May 28, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    458
    Applicant Total
    2
    Review Days
    9

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    Basic Information

    Device Name
    PRO WALKER ML-300 FOLDABLE WHEELCHAIR
    K Number
    K041337
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pro Walker, Inc.
    Date Received
    May 19, 2004
    Decision Date
    May 28, 2004
    Product Code
    IOR
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IOR Wheelchair, Mechanical

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    Other Clearances by Pro Walker, Inc.

    K Number Device Name
    K041336 PRO WALKER PL-200 POWER WHEELCHAIR