BEUDAMED
    Product Code: IMX FDA class 1 21 CFR 890.3910

    Board, Lap, Wheelchair

    Physical Medicine

    A Wheelchair Lap Board is an accessory tray attached to the armrests or frame of a wheelchair to provide a flat working surface for the user, supporting activities of daily living, communication devices, or arm positioning during seated activities. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IMX, regulated under 21 CFR 890.3910, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.

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    510(k)s
    2
    FEI Numbers
    37
    Registration Numbers
    37
    Unique Applicants
    2
    Years Active
    0

    Basic Information

    Product Code
    IMX
    Device Class
    FDA class 1
    Regulation Number
    890.3910
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K780184 WHEELCHAIR ACCESSORIES
    K772401 LAP BOARD W/RIM

    FEI Numbers

    This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.