Identifiers
- 510(k) Number
- K171124 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 Wireless Input Unit WEE-1200 is a wireless component for a full-montage standard electroencephalograph (EEG) system. It facilitates the acquisition, storage, recording, and transmission of cerebral and extracerebral electrical activity, enabling real-time EEG monitoring.
This device is designed for use in long-term epilepsy monitoring, intensive care, and routine EEG settings. Supplied as a reusable, non-sterile component, it operates within Class II regulatory classification (FDA 510(k) clearance, K171124) and supports wireless data transmission for enhanced patient mobility. Compatibility with 32- and 64-channel EEG systems is noted, though specific MRI safety or sterility requirements are not detailed in the specifications.
Frequently asked questions
What clinical settings is the Wireless Input Unit WEE-1200 designed for and how does it improve patient care in those environments?
The Wireless Input Unit WEE-1200 is specifically designed for long-term epilepsy monitoring, intensive care units, and routine EEG settings. It enhances patient care by enabling wireless data transmission, which allows for real-time EEG monitoring without the constraints of wired systems. This mobility feature is particularly beneficial in intensive care and epilepsy monitoring, where patient movement or prolonged observation is necessary, reducing the need for physical connections and potential disruptions to monitoring.
Is the Wireless Input Unit WEE-1200 intended for single-use or reusable applications, and what does this mean for maintenance and cost?
The Wireless Input Unit WEE-1200 is supplied as a reusable component, meaning it is not designed for single-use. This makes it a cost-effective solution in the long term, as it can be cleaned and reused across multiple patients. However, it requires proper maintenance and cleaning protocols to ensure reliability and hygiene, which should be outlined in the manufacturer’s instructions or a dedicated maintenance plan.
What EEG system configurations is the Wireless Input Unit WEE-1200 compatible with, and how does this affect its versatility?
The Wireless Input Unit WEE-1200 is compatible with both 32-channel and 64-channel EEG systems, providing flexibility for different clinical needs. This compatibility ensures it can be integrated into existing EEG infrastructure, whether for standard monitoring or more complex setups requiring higher channel density. The versatility allows clinicians to choose the appropriate system configuration based on their specific diagnostic or research requirements.
How does the regulatory classification of the Wireless Input Unit WEE-1200 impact its use in clinical environments?
The Wireless Input Unit WEE-1200 falls under the FDA’s Class II regulatory classification, which means it has undergone a 510(k) clearance process to demonstrate substantial equivalence to a predicate device. This classification indicates that the device has met FDA standards for safety and effectiveness, allowing it to be used in clinical settings with confidence. However, it is not sterile, so it should not be used in procedures requiring sterile conditions, such as intraoperative monitoring.
What should clinicians consider when storing the Wireless Input Unit WEE-1200 to ensure optimal performance and longevity?
Since the Wireless Input Unit WEE-1200 is a reusable, non-sterile component, it should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of electromagnetic interference. Proper storage conditions are critical to prevent damage to its wireless functionality and physical integrity. Additionally, follow the manufacturer’s guidelines for cleaning and maintenance to ensure consistent performance over time.
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: aireeg (WEE-1200), airEEG (WEE-1200A) - NIHON KOHDEN GLOBAL, Nihon Kohden Wireless Input Unit WEE-1200 (K171124) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171124 | Class II | Active |
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Manufacturer
- Manufacturer
- Nihon Kohden Corporation
Sources (1)
- FDA 510(k) K171124 24 fields · synced Oct 6, 2026