BEUDAMED
    Product Code: ISN FDA class 1 21 CFR 890.3420

    Cable

    Physical Medicine

    A cable in the context of prosthetics is a flexible control cable used within body-powered upper limb prostheses to transmit forces from a harness system to terminal devices or joints, enabling voluntary control of prosthetic components. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ISN, regulated under 21 CFR 890.3420, within the Physical Medicine medical specialty. This device is GMP exempt.

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    510(k)s
    0
    FEI Numbers
    22
    Registration Numbers
    22
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    ISN
    Device Class
    FDA class 1
    Regulation Number
    890.3420
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    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 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.