BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MAINSTREAM ELEVATING WHEEL CHAIR

    K Number: K791408 · Decision Aug 10, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    1
    Review Days
    15

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    Basic Information

    Device Name
    MAINSTREAM ELEVATING WHEEL CHAIR
    K Number
    K791408
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Summit Services, Inc.
    Date Received
    July 26, 1979
    Decision Date
    August 10, 1979
    Product Code
    ITI
    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
    ITI Wheelchair, Powered

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