WaveGuard Net EEG Cap - NA-245
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- waveguard net EUDAMED
- Device Name
- waveguard product family EUDAMED
- Model / Reference
- CA-xxx/CY-xxx/CS-xxx/NA-xxx/NG-xxx/XC-xxx/XE-xxx/XS-xxx EUDAMEDNA-245 EUDAMEDNA-415 EUDAMEDNA-261 EUDAMEDNA-246 EUDAMEDNA-265 EUDAMEDNA-281 EUDAMEDNA-215 EUDAMEDNA-416 EUDAMEDNA-276 EUDAMEDNA-249 EUDAMEDNA-271 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B195NA245 EUDAMED+B195NA415 EUDAMED+B195NA261 EUDAMED+B195NA246 EUDAMED+B195NA265 EUDAMED+B195NA281 EUDAMED+B195NA215 EUDAMED+B195NA416 EUDAMED+B195NA276 EUDAMED+B195NA249 EUDAMED+B195NA271 EUDAMED
- Basic UDI-DI
- ++B195waveguard9J EUDAMED
- Direct Marketing DI
- +B195NA245 EUDAMED+B195NA415 EUDAMED+B195NA261 EUDAMED+B195NA246 EUDAMED+B195NA265 EUDAMED+B195NA281 EUDAMED+B195NA215 EUDAMED+B195NA416 EUDAMED+B195NA276 EUDAMED+B195NA249 EUDAMED+B195NA271 EUDAMED
- 510(k) Number
- K240575 FDA 510(k)
- FDA Product Code
- GXY FDA 510(k)
- EMDN Code
- N01010203 EEG HEADSETS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1320 FDA 510(k)
- Regulation Number
- 882.1320 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K240575 | Class II | Active |
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Manufacturer
- Manufacturer
- Eemagine Medical Imaging Solutions Gmbh
Sources (12)
- FDA 510(k) K240575 24 fields · synced Oct 6, 2026
- EUDAMED fd3339d5-6d0a-4674-9290-adb5c149751e 61 fields · synced Jun 20, 2026
- EUDAMED 20a18ffd-18fe-4e16-bbb8-da40cdfbab7e 61 fields · synced Jul 10, 2026
- EUDAMED 6f972949-f989-4a19-a93c-2433e2392cce 61 fields · synced Jul 10, 2026
- EUDAMED c9283476-80fa-4aa6-a940-5978612494a2 61 fields · synced Jul 12, 2026
- EUDAMED a8efef9c-1d71-4411-9fed-8b9ba7206684 61 fields · synced Jul 14, 2026
- EUDAMED 96ee95db-b070-49b0-8e6f-4f9e1c257cc7 61 fields · synced Jul 18, 2026
- EUDAMED ce4b48c0-910f-4840-94be-f658601530f5 61 fields · synced Jul 20, 2026
- EUDAMED eb4715f8-a13a-4f9e-9ec9-175ca8b0aee3 61 fields · synced Jul 20, 2026
- EUDAMED 771f04d6-4446-4d4d-921c-6dde381cc4bb 61 fields · synced Jul 27, 2026
- EUDAMED ee99cbee-9df2-4232-ba5c-c798c622f14e 61 fields · synced Jul 29, 2026
- EUDAMED 47fc3518-0db1-4c7d-9a4e-b1d60ed0a187 61 fields · synced Aug 2, 2026