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FDA 510(k)

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

K-Number: K171884 · 2017-11-22

ApplicantNeuro Kinetics, Inc.
Decision Date2017-11-22
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

I-Portal Portable Assessment System - Nystagmograph (I-PAS) is a medical device manufactured by Neuro Kinetics, Inc.. It received FDA 510(k) clearance on 2017-11-22 under approval number K171884. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

I-Portal Portable Assessment System - Nystagmograph (I-PAS) is a medical device that received FDA 510(k) clearance on 2017-11-22. It is manufactured by Neuro Kinetics, Inc.. The 510(k) number is K171884.

When was I-Portal Portable Assessment System - Nystagmograph (I-PAS) approved by the FDA?

I-Portal Portable Assessment System - Nystagmograph (I-PAS) received FDA 510(k) clearance on 2017-11-22, under approval number K171884.

What company makes I-Portal Portable Assessment System - Nystagmograph (I-PAS)?

I-Portal Portable Assessment System - Nystagmograph (I-PAS) is manufactured by Neuro Kinetics, Inc..

What is the FDA product code for I-Portal Portable Assessment System - Nystagmograph (I-PAS)?

The FDA product code for I-Portal Portable Assessment System - Nystagmograph (I-PAS) is GWN.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40866856 Prognostic value of nutritional risk assessment indices in patients with digestive system tumors. BMC cancer (2025)

Other Devices by Neuro Kinetics, Inc.

K181025I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System

Related Devices (Code: GWN)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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