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

    MECHANICAL FOLDING WHEEL CHAIR

    K Number: K973491 · Decision Dec 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    458
    Applicant Total
    23
    Review Days
    80

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    Basic Information

    Device Name
    MECHANICAL FOLDING WHEEL CHAIR
    K Number
    K973491
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Heartway Medical Products Co., Ltd.
    Date Received
    September 15, 1997
    Decision Date
    December 4, 1997
    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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