Evox System
The eVox System is intended for the acquisition, display, and storage, of electrical activity of a patient’s brain including electroencephalograph (EEG) and event-related potentials (ERP)…
The eVox System is intended for the acquisition, display, and storage, of electrical activity of a patient’s brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis The medical system includes the “eVox System” amplifier device, accessories, and a computer (laptop computer or tablet device with internal battery and power cord). The hardware and ancillary components used in conjunction with the eVox System include an EEG cap, the eVox Amplifier, a charging kit (that consists of a USB cable, clip kit, and wall adapter), a Subject Response Device and a Base Station laptop computer. The software on the Base Station laptop computer is intended for device functioning
Who Else Makes It
Concentrated in Guangdong (5), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Shenzhen Konmed Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen XFT Medical Limited | Shenzhen | Guangdong | Manufacturer | 8 |
| ISA Mould Engineering Limted | Dongguan | Guangdong | Contract manufacturer | 4 |
| Qinhuangdao Huisianpu Medical Systems Inc. | Qinhuangdao | Hebei | Manufacturer | 4 |
| Shuhai Jingwei(Shenzhen) Information Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Firefly Neuroscience, Israel |
|---|---|
| FDA product code | HCC |
| Device type | Device, Biofeedback |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5050 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2021-10-14 |
| Record revised | 2026-07-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Distribution end date | 2026-07-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EVO-002-400-000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ultium | Noraxon U.S.A., Inc. | 23 |
| FlexiCAP | Deymed Diagnostic S.R.O. | 16 |
| Ondamed | Ondamed Inc. | 15 |
| MyoPro | Myomo, Inc. | 12 |
| TeleMyo | Noraxon U.S.A., Inc. | 12 |
| Recording Cap G1 | Deymed Diagnostic S.R.O. | 8 |
| HAL for Medical Use | Cyberdyne Inc. | 8 |
| Disc Electrode 9mm Sn (Tin) | Deymed Diagnostic S.R.O. | 8 |
| Axon | Exsurgo Limited | 8 |
| Innara Health | Innara Health, Inc. | 7 |
| Kangaroo | Cardinal Health 200, LLC | 7 |
| SX230-1000 EMG Sensor | Biometrics Ltd. | 6 |
Showing 12 of 241. All products under Device, Biofeedback
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.