Axon 2
EEG-based Neurofeedback Headset for use with the Axon mobile App, enabling users to modulate and redirect brain activity towards frequencies associated with relaxation and calm focused…
EEG-based Neurofeedback Headset for use with the Axon mobile App, enabling users to modulate and redirect brain activity towards frequencies associated with relaxation and calm focused attention.
6manufacturers in China registered for this device type
1catalogue number
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 | Exsurgo Limited |
|---|---|
| FDA product code | HCC |
| Device type | Device, Biofeedback |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5050 |
| Premarket notification | Exempt |
| Record published | 2023-05-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 30 to 70 % RH; Storage environment temperature 0 to 55 °C; Storage environment temperature 32 to 131 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100500 | In distribution |
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.