Neuro Kinetics, Inc.

3 devices in the database

  • Model / Serial
    Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed USA (nationwide) and the country of Canada.
  • Product Description
    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.
  • Model / Serial
    Model Numbers NOTC-S, NOTC-P, NOTC-C, NOTC-O, SVNG-1, SVNG-2, SVNG-3
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution - US (nationwide) and Internationally to Canada and Mexico.
  • Product Description
    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.
  • Model / Serial
    models: I-Portal¿ NOTC-O I-Portal¿ NOTC-C,   with S/N 890739 S/N 900140 S/N 900133 S/N 900114 S/N 900172 S/N 900136 S/N 900162 S/N 900134 S/N 900137 S/N 900147 S/N 890739 S/N 900140 S/N 900169 S/N 890738 S/N 900133 S/N 900118 S/N 900127 S/N 900138 S/N 900163 S/N 890742 S/N 890773 S/N 900155 S/N 900150 S/N 900158 S/N 900125 S/N 900123 S/N 900108 S/N 900114 S/N 900160 S/N 900168 S/N 900102 S/N 900130 S/N 900131 S/N 900128 S/N 900144 S/N 890741 S/N 890726 S/N 890736 S/N 900145 S/N 900111 S/N 900119
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide)
  • Product Description
    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.