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Nemus System; Nemus PC Peripheral

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K073415

by EB Neuro S.p.A.

Identifiers

510(k) Number
K073415 FDA 510(k)
FDA Product Code
IKN FDA 510(k)
Models / Variants
Nemus System FDA 510(k)EUDAMED
Nemus Pc Peripheral FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.1375 FDA 510(k)
Regulation Number
890.1375 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Nemus System; Nemus PC Peripheral is a diagnostic electromyograph, classified as a Class II device under FDA regulations. It is designed to record bioelectric signals from peripheral nerves and skeletal muscles, enabling assessment of neuromuscular function through electromyography (EMG) and evoked potential (EP) measurements. The device integrates isolated preamplifiers for signal detection and delivers electrical or auditory stimuli to elicit responses for evaluation.

This system is intended for use in clinical and hospital settings by physicians specializing in physical medicine. It comprises a dedicated amplifier unit (Nemus 1), a host PC, and peripheral components, supplied as a reusable, non-sterile medical device. The Nemus System holds FDA 510(k) clearance and is authorized under the Medical Device Regulation (MDR). No MRI safety classifications or specific storage requirements are noted in the regulatory data.

Frequently asked questions

What clinical specialties primarily use the Nemus System for diagnostic purposes?

The Nemus System is designed for use by physicians specializing in physical medicine, as indicated by its classification under the FDA’s Physical Medicine advisory committee (PM) and its regulatory data. This makes it particularly relevant for clinicians assessing neuromuscular function in patients.

Is the Nemus System reusable or single-use, and what does that mean for my workflow?

The Nemus System is supplied as a reusable, non-sterile medical device, meaning it is intended for multiple uses within a clinical setting. This requires proper cleaning, maintenance, and sterilization procedures between patients to ensure safety and functionality, though no specific sterilization method is detailed in the regulatory data.

What types of bioelectric signals can the Nemus System record, and how does it differ from other electromyographs?

The Nemus System records bioelectric signals from peripheral nerves and skeletal muscles, enabling assessments through electromyography (EMG) and evoked potential (EP) measurements. Unlike some systems, it integrates isolated preamplifiers for signal detection and delivers stimuli (electrical or auditory) to elicit responses, which helps differentiate it from basic EMG devices lacking these features.

What regulatory pathways has the Nemus System followed, and how does that affect its availability?

The Nemus System holds FDA 510(k) clearance (K073415) and is authorized under the Medical Device Regulation (MDR). This means it has undergone FDA review for substantial equivalence to a predicate device and meets EU regulatory standards, ensuring its compliance for use in both U.S. and EU markets where applicable.

Are there any special storage requirements for the Nemus System, or can it be kept with standard medical equipment?

The regulatory data does not specify unique storage requirements for the Nemus System beyond standard conditions for reusable medical devices. Since it is non-sterile and reusable, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures, following general medical equipment guidelines.

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: NeMus 1 - EBNeuro, NEMUS SYSTEM; NEMUS PC PERIPHERAL (K073415) — FDA 510(k) | Innolitics, EMG Systems - Electromyography Devices | EB Neuro, Nemus-Pc Peripheral: Operator Manual Rev. D - Scribd

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) K073415 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026