BEUDAMED
    Product Code: IMO FDA class 1 21 CFR 890.3920

    Handrim, Wheelchair

    Physical Medicine

    A Wheelchair Handrim is the metal or coated ring attached to the outer edge of a manual wheelchair's rear drive wheel, providing the gripping surface through which the user propels the wheelchair by hand. 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 IMO, regulated under 21 CFR 890.3920, within the Physical Medicine medical specialty.

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

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    Basic Information

    Product Code
    IMO
    Device Class
    FDA class 1
    Regulation Number
    890.3920
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    Submission Type
    4

    Device Characteristics

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

    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.