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510(k) Data Aggregation

    K Number
    K150005
    Device Name
    Checkpoint, Checkpoint Head & Neck
    Manufacturer
    Date Cleared
    2015-02-19

    (48 days)

    Product Code
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    NDI Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Checkpoint® Head & Neck is a single-use device intended to provide electrical stimulation of exposed motor nerves or muscle tissue to locate and identify nerves and to test nerve and muscle excitability.
    Device Description
    The Checkpoint Head & Neck is a small handheld device used by a surgeon to deliver electrical stimulation intraoperatively to locate and identify nerves, and to test nerve integrity and muscle excitability. These are sterile disposable devices designed to use with one-handed control. The device uses a stimulating probe that is attached to the distal end and a cable attached to a needle return electrode on the proximal end. The microcontroller in the device includes embedded firmware that controls the function of the Stimulator. The firmware cannot be modified by the user. The stimulator is powered by internal batteries that are not user replaceable, thereby minimizing the potential for re-use.
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    K Number
    K061365
    Device Name
    CHECKPOINT WITH ACCUSTIM TECHNOLOGY
    Manufacturer
    Date Cleared
    2006-07-12

    (57 days)

    Product Code
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    NDI MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Checkpoint™ is a single-use device intended to provide electrical stimulation of exposed motor nerves or muscle tissue to locate and identify nerves and to test nerve and muscle excitability.
    Device Description
    The Checkpoint™ is a small handheld device used by a surgeon to deliver electrical stimulation intraoperatively to test nerve integrity and muscle excitability. This is a sterile disposable device designed to be simple to use with one-handed control.
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    Ask a specific question about this device

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