BEUDAMED
    Product Code: MDR FDA class 1 21 CFR 880.5160

    Binder, Medical, Therapeutic

    General Hospital

    The therapeutic medical binder is a general hospital device worn externally on the body to provide support, compression, or immobilization to anatomical regions such as the abdomen, thorax, or extremities, facilitating recovery or managing certain conditions. It is classified as FDA Class I under 21 CFR 880.5160 within the General Hospital specialty and is GMP-exempt, meaning it is not subject to full quality system regulation requirements. The product code is MDR and the device is not implanted. It does not sustain life.

    View on FDA
    510(k)s
    0
    FEI Numbers
    70
    Registration Numbers
    70
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    MDR
    Device Class
    FDA class 1
    Regulation Number
    880.5160
    Medical Specialty
    General Hospital
    Review Panel
    HO
    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 70 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 70 registration numbers. Click on an entry to view related FDA registrations.