BEUDAMED
    Product Code: IQP FDA class 1 21 CFR 890.3025

    Rotator, Transverse

    Physical Medicine

    A transverse rotator is an external limb prosthetic component that allows controlled rotation between proximal and distal prosthetic segments, accommodating twisting forces during ambulation or activity. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IQP, regulated under 21 CFR 890.3025, within the Physical Medicine medical specialty. This device is GMP exempt.

    View on FDA
    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    IQP
    Device Class
    FDA class 1
    Regulation Number
    890.3025
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K782148 HR UNIT

    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.