BEUDAMED
    Product Code: KGH FDA class 1 21 CFR 890.3420

    Unit, Wrist, External Limb Component, Powered

    Physical Medicine

    Powered External Wrist Unit is a motorized prosthetic component that substitutes for the wrist joint in an upper extremity prosthesis, using electrical power to provide active rotation or flexion-extension of the prosthetic hand or terminal device for patients with wrist-level or more proximal amputations. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KGH, regulated under 21 CFR 890.3420, within the Physical Medicine medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

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    510(k)s
    0
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    KGH
    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 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.