The New Wave Display Unit (DU) is a part of the New Wave System, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to…
The New Wave Display Unit (DU) is a part of the New Wave System, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The Display Unit is the parent device of the Flexset System, intended to: – power the New Wave Head Unit. – aquire the New Wave Head Unit’s signals – transmit the obtained data to the Zeto Cloud Platform – display the currently detected EEG signals – control the recording process.
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1), Shaanxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for New Wave Display Unit | Listed by | Zeto, Inc., United States |
| FDA product code | GWQ |
| Device type | Full-Montage Standard Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Repacker / relabeller |
| 510(k) | K260455 |
| Record published | 2026-06-12 |
Specifications
Specifications | MRI safety | MR Unsafe |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
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.