BEUDAMED
    Product Code: INC FDA class 1 21 CFR 890.3910

    Cuff, Pusher, Wheelchair

    Physical Medicine

    A Wheelchair Pusher Cuff is an assistive device that attaches to the wheelchair handrim or pushrim and fits around the hand or palm of a user with limited hand grip, enabling individuals with hand weakness or paralysis to propel a manual wheelchair without requiring a full grip. 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 INC, 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
    0
    FEI Numbers
    20
    Registration Numbers
    20
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    INC
    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

    FEI Numbers

    This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.