BEUDAMED
    Product Code: MHY FDA class 3

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    Unknown

    The Implanted Electrical Stimulator for Parkinsonian Tremor is a surgically implanted neurostimulation device that delivers controlled electrical pulses to targeted brain regions, such as the subthalamic nucleus or globus pallidus, to reduce or suppress the motor symptoms associated with Parkinson's disease, including tremor and rigidity. As a Class 3 device, it requires Premarket Approval (PMA) due to the high risks associated with implantable brain stimulation. It carries an implant flag and is reviewed by the ENT panel, though no specific regulation number or medical specialty code is recorded.

    View on FDA
    510(k)s
    0
    FEI Numbers
    32
    Registration Numbers
    32
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MHY
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    NE
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.