The Zeto ONE EMG Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments…
The Zeto ONE EMG Cable Extension Set is an accessory of the Zeto ONE, 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 EMG Cable Extension Set is a pair of lead wires with 2.5 mm jack connectors at one end, and snap-on connectors for commonly available adhesive electrodes at the other end. The lead wires are used to record electromyoogram signals.
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 Zeto ONE EMG Cable Extension Set | 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) | K233403 |
| Record published | 2024-06-11 |
| Record revised | 2026-05-28 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
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.