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

    INDEPENDENCE 624

    K Number: K990122 · Decision Jun 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    2
    Review Days
    163

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    Basic Information

    Device Name
    INDEPENDENCE 624
    K Number
    K990122
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Eagle Parts & Products, Inc.
    Date Received
    January 13, 1999
    Decision Date
    June 25, 1999
    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 Eagle Parts & Products, Inc.

    K Number Device Name
    K990484 INDEPENDENCE 324