BEUDAMED
    Product Code: ITO FDA class 1 21 CFR 890.3410

    Twister, Brace Setting

    Physical Medicine

    A brace setting twister is an orthotic component consisting of spiral or coiled cables attached between a belt and the brace uprights, used to apply rotational torque to the lower limb to correct or manage rotational gait abnormalities. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ITO, regulated under 21 CFR 890.3410, within the Physical Medicine medical specialty. This device is GMP exempt.

    View on FDA
    510(k)s
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    ITO
    Device Class
    FDA class 1
    Regulation Number
    890.3410
    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
    K800716 ORTHOTIC LEG GAIT CORRECTOR DEVICE

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.