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

    ALANTE, BATTERY OPERATED POWER WHEELCHAIR

    K Number: K011153 · Decision May 29, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    8
    Review Days
    43

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    Basic Information

    Device Name
    ALANTE, BATTERY OPERATED POWER WHEELCHAIR
    K Number
    K011153
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Golden Technologies, Inc.
    Date Received
    April 16, 2001
    Decision Date
    May 29, 2001
    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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