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

    Xpedition ™ Powered Stair Chair (625700000000)

    K Number: K222818 · Decision Jan 24, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    35
    Applicant Total
    14
    Review Days
    127

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    Basic Information

    Device Name
    Xpedition ™ Powered Stair Chair (625700000000)
    K Number
    K222818
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5150
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Medical
    Date Received
    September 19, 2022
    Decision Date
    January 24, 2023
    Product Code
    ILK
    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
    ILK Transport, Patient, Powered

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