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

by Neuro Kinetics, Inc.

510(k) K171884

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK171884 Date22 Nov 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GWN
Device Class
Class II
Regulation
21 CFR Part 882.1460
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The I-Portal Portable Assessment System - Nystagmograph (I-PAS) is a nystagmograph used in vestibular and neuro otologic diagnostic testing. It provides visual stimuli to a patient, monitors the patient's response, and presents the data for interpretation by qualified medical personnel trained in vestibular diagnostic testing.

The device is supplied by Neuro Kinetics, Inc. and has received FDA 510(k) clearance under K171884 with product code GWN. It is classified as a Class II device under regulation number 882.1460 and is intended for use in neurology-related diagnostic assessments.

Other devices from Neuro Kinetics, Inc.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the I-Portal Portable Assessment System - Nystagmograph (I-PAS) used for?

    The I-Portal Portable Assessment System - Nystagmograph (I-PAS) is used in vestibular and neuro-otologic diagnostic testing to provide visual stimuli to a patient, monitor the patient's response, and present data for interpretation by qualified medical personnel trained in vestibular diagnostic testing.

  • How is the I-Portal Portable Assessment System - Nystagmograph (I-PAS) supplied and what is its regulatory status?

    The device is supplied by Neuro Kinetics, Inc. and has received FDA 510(k) clearance under K171884 with product code GWN. It is classified as a Class II device under regulation number 882.1460 and is intended for use in neurology-related diagnostic assessments.

  • Who is intended to operate or interpret results from the I-Portal Portable Assessment System - Nystagmograph (I-PAS)?

    The I-Portal Portable Assessment System - Nystagmograph (I-PAS) is intended for use by qualified medical personnel trained in vestibular diagnostic testing, as it presents data for interpretation by such professionals following patient response monitoring during vestibular and neuro-otologic assessments.