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NeuroTrac Nerve Stimulator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K831715

by Hdc Corp.

Identifiers

510(k) Number
K831715 FDA 510(k)
FDA Product Code
ETN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.1820 FDA 510(k)
Regulation Number
874.1820 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The NeuroTrac is a nerve stimulator, classified as a Class II medical device under FDA regulation 874.1820. It is designed to deliver electrical stimulation to nerves for diagnostic or therapeutic purposes, commonly used in otolaryngology procedures.

This device is intended for single-use or reusable applications in clinical settings, depending on the specific model. It is regulated under the FDA’s 510(k) clearance (K831715) and falls under the Ear, Nose, and Throat (ENT) advisory committee category. No MRI safety information or sterility details are specified in the available data.

Frequently asked questions

What types of procedures is the NeuroTrac nerve stimulator commonly used for in clinical settings?

The NeuroTrac nerve stimulator is primarily designed for use in otolaryngology procedures, delivering electrical stimulation to nerves for diagnostic or therapeutic purposes. Its regulatory classification and advisory committee category (Ear, Nose, and Throat) further support its application in ENT-related evaluations or treatments.

Is the NeuroTrac nerve stimulator intended for single-use or reusable applications, and how should it be handled?

The NeuroTrac is designed for both single-use and reusable applications, depending on the specific model. While the data does not specify sterilization methods, reusable models would require adherence to standard medical device reprocessing protocols to ensure safety and efficacy. Always follow manufacturer guidelines for handling and reprocessing.

What regulatory pathway was followed for the NeuroTrac nerve stimulator, and how does this affect its use?

The NeuroTrac nerve stimulator received FDA clearance through a 510(k) submission (K831715), classified as a Class II device under regulation 21 CFR 874.1820. This means it was determined to be *substantially equivalent* to a legally marketed predicate device, ensuring compliance with FDA standards for safety and effectiveness. The clearance falls under the Ear, Nose, and Throat (ENT) advisory committee category, reflecting its intended use in specialized procedures.

Are there multiple models or variations of the NeuroTrac nerve stimulator, and if so, how can I identify them?

The NeuroTrac nerve stimulator appears in multiple FEI (Final Establishment Identification) numbers and registration numbers in FDA records, suggesting there may be variations or different lot/serialized models. While exact specifications (e.g., output settings, electrode types) aren’t detailed here, these identifiers can help trace specific versions through regulatory databases. Always verify the model against the manufacturer’s documentation or labeling for precise compatibility.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NEUROTRAC (K831715) — FDA 510(k) | Innolitics, NEUROTRAC 510 (k) K831715 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hdc Corp.

Sources (1)

  • FDA 510(k) K831715 24 fields · synced Sep 18, 2026