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

    AMIGO ESCORT 7.5, MODEL 760001 PHS

    K Number: K092936 · Decision Dec 4, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    8
    Review Days
    71

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    Basic Information

    Device Name
    AMIGO ESCORT 7.5, MODEL 760001 PHS
    K Number
    K092936
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Amigo Mobility Intl., Inc.
    Date Received
    September 24, 2009
    Decision Date
    December 4, 2009
    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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    Other Clearances by Amigo Mobility Intl., Inc.

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