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

    ExoAtlet-II

    K Number: K201473 · Decision Jul 16, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    408

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    Basic Information

    Device Name
    ExoAtlet-II
    K Number
    K201473
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3480
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exoatlet Asia Co. , Ltd.
    Date Received
    June 3, 2020
    Decision Date
    July 16, 2021
    Product Code
    PHL
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PHL Powered Exoskeleton

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