Nurochek-Pro Headset
The Nurochek-Pro System is a medical device that consist of a headset that evokes and records steady-state visual-evoked potentials (SSVEP) via electroencephalography (EEG). The…
The Nurochek-Pro System is a medical device that consist of a headset that evokes and records steady-state visual-evoked potentials (SSVEP) via electroencephalography (EEG). The Nurochek-Pro headset communicates to a computer via an isolated USB-A connection, of which allows for user control of the device via a custom software Application (App). The App communicates with a cloud-based Server that stores and processes Nurochek data using a proprietary classification algorithm. The product requires internet connection to login to the application and process data.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Headsafe MFG PTY Ltd, Australia |
|---|---|
| FDA product code | OMC |
| Device type | Reduced- Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Manufacturer |
| 510(k) | K243426 |
| Record published | 2025-12-15 |
| Record revised | 2026-03-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 620 to 1060 millibar; Storage environment humidity 10 to 80 % RH; Storage environment temperature 0 to 50 °C |
| Distribution end date | 2026-03-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Nurochek-Pro Headset Assembly (HS03-267) | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| X-Series | Advanced Brain Monitoring, Inc. | 59 |
| Sleep Profiler PSG2 | Advanced Brain Monitoring, Inc. | 22 |
| Sleep Profiler | Advanced Brain Monitoring, Inc. | 13 |
| Remi | Epitel | 12 |
| Natus | Xltek | 5 |
| Narcotrend Patient lead | MT Monitortechnik Gmbh & Co. KG | 2 |
| Reduced- Montage Standard Electroencephalograph | GE Healthcare Finland OY | 2 |
| Quex S | QX World KFT | 2 |
| AE-120A EEG Head Set | Nihon Kohden Corp. | 2 |
| VitalEEG Portable System | Nihon Kohden America, Inc. | 2 |
| Nurochek-Pro | Headsafe MFG PTY Ltd | 2 |
| Quex ED | QX World KFT | 2 |
Showing 12 of 87. All products under Reduced- Montage Standard Electroencephalograph
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.