BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ICON 35; ICON 45; ICON 60; ICON 30FAF

    K Number: K260849 · Decision Jun 11, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    458
    Applicant Total
    1
    Review Days
    87

    Basic Information

    Device Name
    ICON 35; ICON 45; ICON 60; ICON 30FAF
    K Number
    K260849
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rehasense USA, Inc.
    Date Received
    March 16, 2026
    Decision Date
    June 11, 2026
    Product Code
    IOR
    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
    IOR Wheelchair, Mechanical

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