BEUDAMED
    Product Code: IQO FDA class 1 21 CFR 890.3025

    Device, Prosthesis Alignment

    Physical Medicine

    A prosthesis alignment device is a tool used by prosthetists and orthotists to accurately measure and set the alignment of prosthetic limb components, ensuring correct biomechanical function. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IQO, regulated under 21 CFR 890.3025, within the Physical Medicine medical specialty. This device is GMP exempt.

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    510(k)s
    0
    FEI Numbers
    47
    Registration Numbers
    47
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    IQO
    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

    FEI Numbers

    This FDA classification entry is associated with 47 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 47 registration numbers. Click on an entry to view related FDA registrations.