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WaveGuard Net EEG Cap - NA-265

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K240575

by Eemagine Medical Imaging Solutions Gmbh

Identifiers

510(k) Number
K240575 FDA 510(k)
FDA Product Code
GXY FDA 510(k)
Models / Variants
NA-245 FDA 510(k)EUDAMED
NA-255 FDA 510(k)EUDAMED
NA-261 FDA 510(k)EUDAMED
NA-265 FDA 510(k)EUDAMED
NA-271 FDA 510(k)EUDAMED
NA-281 FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1320 FDA 510(k)
Regulation Number
882.1320 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The WaveGuard Net EEG Cap is a disposable, net-style electrode cap designed for electroencephalography (EEG) recording. It features a flexible, stretchable net with integrated electrodes arranged in a standardized configuration to capture brainwave activity accurately across multiple scalp locations.

Supplied in sterile packaging, the cap is intended for single-use and is compatible with standard EEG acquisition systems. Available in multiple sizes (NA-245 through NA-281) to accommodate different head circumferences, it requires no additional preparation beyond proper positioning. Authorized under FDA 510K and MDR, it adheres to regulatory standards for EEG monitoring devices.

Frequently asked questions

What sizes are available for the WaveGuard Net EEG Cap, and how do I determine the correct fit for a patient’s head?

The WaveGuard Net EEG Cap comes in six sizes: NA-245, NA-255, NA-261, NA-265, NA-271, and NA-281, designed to accommodate a range of head circumferences. To select the appropriate size, measure the patient’s head circumference at its widest point (typically around the hairline). The manufacturer provides sizing guidelines in their user manual, but generally, the NA-261 and NA-265 are common mid-range options for average adult heads, while smaller or larger sizes cater to pediatric or larger adult patients, respectively.

Is the WaveGuard Net EEG Cap reusable, or is it intended for single-use only? How does this affect its sterility?

The WaveGuard Net EEG Cap is explicitly designed for single-use only, as stated in the manufacturer’s description. This ensures sterility since it is supplied in sterile packaging, eliminating the need for cleaning or reprocessing between uses. Single-use also reduces the risk of cross-contamination and maintains consistent performance for accurate EEG recordings.

How does the WaveGuard Net EEG Cap differ from traditional EEG electrode caps in terms of setup and preparation?

Unlike traditional EEG caps that may require gel application, electrode placement adjustments, or multiple attachment steps, the WaveGuard Net EEG Cap is a net-style design with integrated electrodes that stretch and conform to the scalp. This eliminates the need for additional preparation beyond proper positioning—no gel application or manual electrode placement is required. The flexible net ensures consistent contact across multiple scalp locations, simplifying setup while maintaining accuracy for brainwave recording.

What regulatory pathways has the WaveGuard Net EEG Cap undergone, and what does this mean for clinical use?

The WaveGuard Net EEG Cap has been authorized through FDA 510K clearance (K240575) and MDR compliance, confirming it meets regulatory standards for EEG monitoring devices. The Neurology (NE) Advisory Committee reviewed its submission, and the clearance was granted under the Traditional 510(k) pathway, meaning it was deemed substantially equivalent to a legally marketed predicate device. Clinically, this indicates the cap has undergone rigorous evaluation for safety and performance, ensuring reliability for diagnostic EEG applications.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Eemagine Medical Imaging Solutions Gmbh

Sources (2)

  • FDA 510(k) K240575 24 fields · synced Oct 7, 2026
  • EUDAMED 1 fields · synced Jun 19, 2026