I-Portal 4D Video Oculography Eye Tracking System (Vog), I-Portal Video Nystagmography System (Vng), I-Portal Neuro Otol

• • Terminated Z-2730-2015 FDA Class II ·initiated 21 Jul 2015

  The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.

• • Terminated Z-1795-2015 FDA Class II ·initiated 30 Apr 2015

  complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.

• • Terminated Z-0966-2014 FDA Class II ·initiated 21 Nov 2013

  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.

• • Terminated Z-2253-2009 FDA Unclassified (pre-2012) ·initiated 24 Jul 2009 ·on shared 510(k) K083603

  Marketed without a 510k or PMA submission to include the normative data display.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K083603 ↗

FDA Product Code

GWN

Device Class

Class II

Regulation

21 CFR Part 882.1460

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• I-Portal Portable Assessment System - Nystagmograph (I-PAS)

  Class II

  FDA 510(k) K171884 Active Cleared 22 Nov 2017

• I-Portal NOTC, VNG and VOG

  Class II

  FDA 510(k) K143607 Active Cleared 8 Jul 2015

• I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System

  Class II

  FDA 510(k) K181025 Active Cleared 24 Jul 2018