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

    iBOT® PMD

    K Number: K243442 · Decision Jan 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    85

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    Basic Information

    Device Name
    iBOT® PMD
    K Number
    K243442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3890
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mobius Mobility
    Date Received
    November 6, 2024
    Decision Date
    January 30, 2025
    Product Code
    IMK
    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
    IMK Wheelchair, Stair Climbing

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IMK), ordered by most recent decision date.

    iBOT Personal Mobility Device (iBOT PMD)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Next Generation iBOT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Mobius Mobility

    K Number Device Name
    K210920 iBOT Personal Mobility Device (iBOT PMD)