BEUDAMED
    Product Code: IRS FDA class 1 21 CFR 890.5925

    Head Halter, Traction

    Physical Medicine

    A head halter traction device is a cervical traction apparatus that fits over the head and chin to apply longitudinal traction to the cervical spine for pain relief and decompression of cervical structures. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IRS, regulated under 21 CFR 890.5925, within the Physical Medicine medical specialty. This device is GMP exempt.

    View on FDA
    510(k)s
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    IRS
    Device Class
    FDA class 1
    Regulation Number
    890.5925
    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
    K770724 TRACTION DEVICES, INTERMITTENT, TX

    FEI Numbers

    This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.