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

    Action Trackchair Hawk

    K Number: K202728 · Decision Feb 10, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    65
    Applicant Total
    3
    Review Days
    510

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    Basic Information

    Device Name
    Action Trackchair Hawk
    K Number
    K202728
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3900
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Action Manufacturing, Inc.
    Date Received
    September 18, 2020
    Decision Date
    February 10, 2022
    Product Code
    IPL
    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
    IPL Wheelchair, Standup

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    Other Clearances by Action Manufacturing, Inc.

    K Number Device Name
    K181908 Action Trackchair
    K163451 Action Trackstander models TR1816, TR1820, TR2016, and TR2020