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

    PENOX PERFORMER WHEELCHAIR

    K Number: K852109 · Decision Aug 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    458
    Applicant Total
    10
    Review Days
    99

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    Basic Information

    Device Name
    PENOX PERFORMER WHEELCHAIR
    K Number
    K852109
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Penox Technologies, Inc.
    Date Received
    May 15, 1985
    Decision Date
    August 22, 1985
    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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