BEUDAMED
    Product Code: QPY FDA class 3

    Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

    Unknown

    The Implanted Autonomic Nerve Stimulator for Stroke Rehabilitation is a Class 3 implantable device that stimulates the vagus nerve, intended to support neurological rehabilitation following stroke, requiring Premarket Approval (PMA) due to its high-risk implantable nature. No regulation number is assigned; it is reviewed by the Physical Medicine panel. Product code QPY. The device is flagged as an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    0
    Years Active
    —

    Research product code QPY in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    QPY
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    PM
    Submission Type
    2

    Device Characteristics

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

    Definition

    Stimulation of the vagus nerve

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.