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    Neuro Kinetics Inc

    FDA UDI
    N K I·B290NOTC0·Nystagmograph

    NEURO KINETICS BARANY CHAIR SYSTEM

    FDA Adverse Event
    Injury ·NEURO KINETICS, INC.·Product code GWN·January 9, 2012

    I-PORTAL NEURO-OTOLOGICAL TEST CENTER

    FDA Adverse Event
    Injury ·NEURO-KINETICS INC.·Product code GWN·February 16, 2012

    VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing.

    FDA Recall
    Terminated ·Neuro Kinetics·Product code LXV·July 24, 2009

    Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

    FDA Recall
    Terminated ·Neuro Kinetics, Inc.·Product code GWN·July 21, 2015

    Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

    FDA Enforcement
    Class II ·Terminated·Neuro Kinetics, Inc.·September 9, 2015

    Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

    FDA Recall
    Terminated ·Neuro Kinetics, Inc.·Product code GWN·November 21, 2013

    I-Portal NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of central vs. peripheral nervous system deficits.

    FDA Recall
    Terminated ·Neuro Kinetics, Inc.·Product code GWN·April 30, 2015

    I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of central vs. peripheral nervous system deficits.

    FDA Enforcement
    Class II ·Terminated·Neuro Kinetics, Inc.·June 24, 2015

    Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

    FDA Enforcement
    Class II ·Terminated·Neuro Kinetics, Inc.·February 19, 2014