FDA-Device2015-09-09Class II
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.
Neuro Kinetics, Inc.
Hazard
The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.
Sold states
Worldwide Distribution - US (nationwide)
Affected count
45
Manufactured in
128 Gamma Dr, N/A, Pittsburgh, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2730-2015Don't want to check this manually?
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