BEUDAMED
    Product Code: IMK FDA class 2 21 CFR 890.3890

    Wheelchair, Stair Climbing

    Physical Medicine

    A Stair Climbing Wheelchair is a powered wheelchair or mobility device specifically designed to ascend and descend stairs, enabling users with mobility impairments to independently navigate environments with stairways. As noted in the regulatory record, a PMA (Premarket Approval Application) was required to be filed by July 12, 2000, per 65 FR 19834. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification; however, this record indicates a PMA filing requirement, and manufacturers should consult current FDA guidance. The product code is IMK, regulated under 21 CFR 890.3890, within the Physical Medicine medical specialty.

    View on FDA
    510(k)s
    3
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    2
    Years Active
    7

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    Basic Information

    Product Code
    IMK
    Device Class
    FDA class 2
    Regulation Number
    890.3890
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K243442 iBOT® PMD
    K210920 iBOT Personal Mobility Device (iBOT PMD)
    K172601 Next Generation iBOT

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.