BEUDAMED
    Product Code: KTD FDA class 1 21 CFR 890.3490

    Orthosis, Abdominal

    Physical Medicine

    This device is an abdominal orthosis, a rigid, semi-rigid, or flexible brace or support garment worn around the abdomen to provide support to weakened or injured abdominal musculature, used in post-surgical recovery, hernia management, or abdominal wall conditions. It is classified as FDA Class 1, indicating low risk, subject to general controls only. The product code is KTD, regulated under 21 CFR 890.3490 within the Physical Medicine specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

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    510(k)s
    3
    FEI Numbers
    83
    Registration Numbers
    83
    Unique Applicants
    2
    Years Active
    5

    Basic Information

    Product Code
    KTD
    Device Class
    FDA class 1
    Regulation Number
    890.3490
    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 3 510(k) clearances via K numbers.

    K Number Device Name
    K823663 ABDOMINAL BINDER
    K823164 ABDOMINAL BINDER
    K780229 ABDOMINAL BELT

    FEI Numbers

    This FDA classification entry is associated with 83 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 83 registration numbers. Click on an entry to view related FDA registrations.