BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BONUS MECHANICAL WHEELCHAIR

    K Number: K001391 · Decision Jul 24, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    445
    Applicant Total
    1
    Review Days
    83

    Basic Information

    Device Name
    BONUS MECHANICAL WHEELCHAIR
    K Number
    K001391
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BONUS ENT. CORP.
    Date Received
    May 2, 2000
    Decision Date
    July 24, 2000
    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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