BEUDAMED
    Product Code: QRB FDA class 3

    Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy

    Unknown

    The Stimulator, Spinal-Cord, Totally Implanted for Relief of Pain Due to Diabetic Neuropathy is a fully implanted neurostimulation device intended to relieve chronic pain in patients with diabetic neuropathy through electrical stimulation of the spinal cord. As a Class 3 device requiring Premarket Approval (PMA), it is subject to the most stringent FDA regulatory controls and must demonstrate reasonable assurance of safety and effectiveness through clinical evidence. No regulation number is assigned; it is reviewed under the Neurology panel. Notably, this device is flagged as an implant given its totally implanted design.

    View on FDA
    510(k)s
    0
    FEI Numbers
    35
    Registration Numbers
    35
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QRB
    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

    Definition

    To relieve pain in patients with diabetic neuropathy

    FEI Numbers

    This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.