BWMini EEG, BWMiniHST, BWMini PSG
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131335 FDA 510(k)
- FDA Product Code
- GWQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1400 FDA 510(k)
- Regulation Number
- 882.1400 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BWMini EEG, BWMiniHST, and BWMini PSG are multi-channel electroencephalographs (EEG) designed for recording electrical brain activity via scalp electrodes. These devices are classified as Full-Montage Standard Electroencephalographs and are used to monitor brain wave patterns for diagnostic purposes in neurology.
These systems are portable, battery-powered, and capable of performing EEG, Home Sleep Tests (HST), and Polysomnography (PSG) with up to 32 channels. They are intended for use in clinical, ambulatory, home, and research settings by healthcare professionals. Supplied with hardware and Windows-based analysis software, the devices store recorded data on memory cards and provide raw signal display. Authorized under FDA 510(k) clearance (K131335) and MDR, they are classified as Class II medical devices under regulation number 882.1400.
Frequently asked questions
What clinical settings can the BWMini EEG, BWMiniHST, and BWMini PSG be used in, and why are they designed for portability?
The BWMini EEG, BWMiniHST, and BWMini PSG are designed for use in clinical, ambulatory, home, and research settings, making them versatile for various environments. Their portable, battery-powered design allows for flexibility in monitoring brain activity outside traditional hospital walls, such as in patient homes or mobile clinics. This is particularly useful for long-term or at-home diagnostics, like home sleep tests (HST) or extended EEG monitoring, where mobility and ease of use are critical.
How many channels do these devices support, and what types of recordings can they perform?
The BWMini EEG, BWMiniHST, and BWMini PSG systems support up to 32 channels, enabling detailed recording of electrical brain activity. They are capable of performing EEG (electroencephalography), Home Sleep Tests (HST), and Polysomnography (PSG), making them suitable for diagnosing neurological conditions, sleep disorders, and other brain-related assessments in a single portable device.
Are these devices single-use or reusable, and how is data stored for later analysis?
The BWMini EEG, BWMiniHST, and BWMini PSG are not single-use—they are designed for reusable clinical use in multiple patient sessions. Recorded data is stored on memory cards, allowing for later transfer to the included Windows-based analysis software for review and interpretation by healthcare professionals.
What regulatory pathways have these devices undergone, and what does that mean for their use?
These devices have been authorized through FDA 510(k) clearance (K131335) and MDR (Medical Device Regulation) under the EU framework, confirming they meet safety and performance standards. This means they are classified as Class II medical devices under FDA regulation 882.1400, ensuring they are suitable for professional use in neurology and sleep diagnostics while adhering to strict regulatory requirements.
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: BWMini PSG - Neurovirtual, BWMINI EEG, BWMINIHST, BWMINI PSG (K131335) — FDA 510(k) | Innolitics, BWMINI EEG, BWMINIHST, BWMINI PSG 510(k) K131335 - FDA.report
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 | K131335 | Class II | Active |
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Manufacturer
- Manufacturer
- Neurovirtual Usa, Inc.
Sources (2)
- FDA 510(k) K131335 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026