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NExT Station - NExT Station

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K242832

by EB Neuro S.p.A.

Identifiers

510(k) Number
K242832 FDA 510(k)
FDA Product Code
GWL FDA 510(k)
Models / Variants
NExT Station FDA 510(k)EUDAMED
NExT Station Advanced FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1835 FDA 510(k)
Regulation Number
882.1835 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The NExT Station and NExT Station Advanced are physiological signal amplifiers designed for electromyography (EMG), electroneurography (ENG), and evoked potentials (EP) testing. These devices acquire bioelectric signals from the central and peripheral nervous systems, as well as muscle activity, enabling precise diagnostic assessments in neurology.

The systems are supplied in two configurations: all-in-one and portable, with varying dimensions to accommodate different clinical environments. Both versions are intended for single-use or reusable applications, though sterility and regulatory compliance depend on the specific clinical setting and manufacturer guidelines. The devices are classified as Class II under FDA regulations and are authorized via 510(k) clearance and MDR compliance. They operate with Galileo NT Line software for signal processing and remote control via an external tablet.

Frequently asked questions

What types of neurological tests can the NExT Station be used for, and how does it differ from standard EMG equipment?

The NExT Station is specifically designed for electromyography (EMG), electroneurography (ENG), and evoked potentials (EP) testing, allowing it to capture bioelectric signals from the central and peripheral nervous systems as well as muscle activity. Unlike standard EMG equipment, it integrates advanced signal processing through the Galileo NT Line software, enabling more precise diagnostic assessments in neurology. Its dual configurations (all-in-one and portable) also make it adaptable to various clinical environments.

Is the NExT Station meant for single-use or reusable applications, and how should it be handled in a clinical setting?

The NExT Station can be used for either single-use or reusable applications, depending on the clinical setting and manufacturer guidelines. Sterility and regulatory compliance must be carefully followed to ensure safe use. If reused, it should be cleaned and maintained according to the manufacturer’s instructions to prevent contamination and ensure accurate signal acquisition.

What software is required to operate the NExT Station, and can it be controlled remotely?

The NExT Station operates with the Galileo NT Line software for signal processing. Additionally, it supports remote control via an external tablet, allowing clinicians to manage the device and analyze data from a distance, which can improve workflow efficiency in clinical settings.

Are there different sizes or configurations available for the NExT Station, and how might that affect its use in a hospital?

Yes, the NExT Station is available in two configurations: an all-in-one version and a portable version, with varying dimensions to suit different clinical environments. The all-in-one model may be better suited for fixed laboratory setups, while the portable version offers flexibility for use in patient rooms or mobile testing units, depending on the hospital’s layout and workflow needs.

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: NExT Station Advanced - EBNeuro, NExT Station - EBNeuro, NExT Station; NExT Station Advanced (K242832) — FDA 510(k) | Innolitics

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
EB Neuro S.p.A.

Sources (2)

  • FDA 510(k) K242832 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026