Neuro Kinetics, Inc.
Neuro Kinetics, Inc. holds FDA 510(k) medical device clearances, first cleared 2015, most recent 2018, with 3 FDA device recalls on record.
Top product codes for Neuro Kinetics, Inc.
FDA recalls by Neuro Kinetics, Inc.
- Z-2730-2015 — 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.
- Z-1795-2015 — 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.
- Z-0966-2014 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Neuro Kinetics, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.