Neuro Kinetics, Inc.
Medical device manufacturer in Pittsburgh, PA.
4510(k) clearances
0PMA approvals
4recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal…GWN · Special | 07/24/2018SE |
| K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS)GWN · Traditional | 11/22/2017SE |
| K143607 | I-Portal NOTC, VNG and VOGGWN · Traditional | 07/08/2015SE |
| K083603 | I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video Nystagmography…GWN · Traditional | 08/06/2009SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2730-2015 Class II | Neuro Kinetics, Inc. (NKI) I-Portal NOTC system with the OVAR research test; a rotary…The devices that included the OVAR research test were not cleared for marketing and mTBI research package… | 07/21/2015Terminated |
| Z-1795-2015 Class II | I-Portal NOTC and VNG; a device used to measure, record, or visually display the…complaints of system malfunction and unintended, sudden movement at start up. No injuries reported. | 04/30/2015Terminated |
| Z-0966-2014 Class II | Normative Data Template CD for use with the I-Portal devices. Used to measure, record…The data provided on the Normative Data Template CD for use with the I-Portal devices has not received… | 11/21/2013Terminated |
| Z-2253-2009 | VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used…Marketed without a 510k or PMA submission to include the normative data display. | 07/24/2009Terminated |