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

    Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE

    K Number: K111278 · Decision Sep 16, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    17
    Review Days
    134

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    Basic Information

    Device Name
    Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE
    K Number
    K111278
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Otto Bock Healthcare LP
    Date Received
    May 5, 2011
    Decision Date
    September 16, 2011
    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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