The New Wave Head Unit - Regular is a detachable part of the New Wave, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments…
The New Wave Head Unit – Regular is a detachable part of the New Wave, 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 with head circumference of approximately 50-65 cm, not including newborns. The Head Unit – Regular component of the New Wave System is intended to hold electrodes on the subject’s scalp and aquire electric signals produced by human brain activity.
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 Head Unit – Regular | 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.