BEUDAMED
    Product Code: IRE FDA class 1 21 CFR 890.3420

    Joint, Elbow, External Limb Component, Powered

    Physical Medicine

    A powered external limb component elbow joint is an electrically or pneumatically actuated prosthetic joint providing elbow flexion and extension for upper limb amputees above the elbow level. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IRE, regulated under 21 CFR 890.3420, within the Physical Medicine medical specialty. This device is GMP exempt.

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    510(k)s
    2
    FEI Numbers
    15
    Registration Numbers
    15
    Unique Applicants
    2
    Years Active
    2

    Basic Information

    Product Code
    IRE
    Device Class
    FDA class 1
    Regulation Number
    890.3420
    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
    K822632 ELBOW PROSTHESIS
    K802642 UTAH ARTIFICAL ARM

    FEI Numbers

    This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.