Company ยท US
Neuro Kinetics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2018. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2018 | K181025 | I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking Syste Neuro Kinetics, Inc. | GWN |
| Nov 22, 2017 | K171884 | I-Portal Portable Assessment System - Nystagmograph (I-PAS) Neuro Kinetics, Inc. | GWN |
| Jul 8, 2015 | K143607 | I-Portal NOTC, VNG and VOG Neuro Kinetics, Inc. | GWN |
| Aug 6, 2009 | K083603 | I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL Neuro Kinetics | GWN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2015 | Neuro Kinetics, Inc. 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 Terminated |
GWN | K083603 K143607 |
| Jun 12, 2015 | Neuro Kinetics, Inc. 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 i Terminated |
GWN | K083603 |
| Feb 10, 2014 | Neuro Kinetics, Inc. 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. Terminated |
GWN | K083603 |
| Sep 30, 2009 | Neuro Kinetics VEST 6.6 or earlier software for use with Neuro Kinetics products.
The device is used for vestibular testing. Terminated |
LXV | K083603 |