BEUDAMED
    Product Code: ILE FDA class 1 21 CFR 890.3475

    Sling, Arm, Overhead Supported

    Physical Medicine

    An Overhead Supported Arm Sling is a Physical Medicine orthotic device that suspends the upper limb from an overhead support structure, used to reduce the effects of gravity on a weakened or paralyzed arm, enabling patients to perform functional arm movements during rehabilitation. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is ILE, regulated under 21 CFR 890.3475, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.

    View on FDA
    510(k)s
    3
    FEI Numbers
    82
    Registration Numbers
    82
    Unique Applicants
    3
    Years Active
    0

    Basic Information

    Product Code
    ILE
    Device Class
    FDA class 1
    Regulation Number
    890.3475
    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

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K830842 OB HELP ARM
    K823811 OVERHEAD ARM SLINGS
    K823152 OB HELP ARM

    FEI Numbers

    This FDA classification entry is associated with 82 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 82 registration numbers. Click on an entry to view related FDA registrations.