Neuro Kinetics, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What Neuro Kinetics, Inc. makes
Neuro Kinetics, Inc. manufactures diagnostic systems for vestibular and ocular function testing, including portable assessment tools like the I-Portal Portable Assessment System (I-PAS) and specialized units for nystagmography, video nystagmography (VNG), video oculography (VOG), and neuro-otologic evaluations. These devices are designed to measure eye movements and vestibular responses, aiding in the assessment of balance disorders, dizziness, and related neurological conditions. The I-Portal Neuro Otologic Test Center integrates multiple testing modalities into a single platform for comprehensive diagnostic evaluations.
The company’s products fall under FDA Class II regulatory classification and are listed via the 510(k) pathway. These devices are intended for use in clinical settings to support diagnostic procedures. Neuro Kinetics, Inc. is headquartered in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
I-Portal NOTC, VNG and VOG Ref K143607
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 4 recalls initiated by Neuro Kinetics, Inc., the earliest on 2009-07-24 and the most recent on 2015-07-21. By recorded status: 4 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 21 Jul 2015 Z-2730-2015 Class II Terminated The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.
- 30 Apr 2015 Z-1795-2015 Class II Terminated complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.
2013
- 21 Nov 2013 Z-0966-2014 Class II Terminated The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process.
2009
- 24 Jul 2009 Z-2253-2009 Unclassified (pre-2012) Terminated Marketed without a 510k or PMA submission to include the normative data display.
Full distribution text
- 24 Jul 2009 Z-2253-2009 Unclassified (pre-2012) Terminated Marketed without a 510k or PMA submission to include the normative data display.
Frequently asked questions
How many devices does Neuro Kinetics, Inc. have in the registry?
The registry currently lists 4 devices for Neuro Kinetics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neuro Kinetics, Inc.'s devices?
Among its 4 most recently registered devices, Neuro Kinetics, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Neuro Kinetics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Neuro Kinetics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Neuro Kinetics, Inc.?
FDA recall records list 4 recalls initiated by Neuro Kinetics, Inc., the most recent initiated on 21 Jul 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Neuro Kinetics, Inc. in the registry?
The most recently registered devices listed for Neuro Kinetics, Inc. include I-Portal Portable Assessment System - Nystagmograph (I-PAS), I-Portal NOTC, VNG and VOG, I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL and I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System.