Identity
- Trade Name
- Axon 2 FDA UDI
- Generic Name
- Psychophysiological biofeedback system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 100500 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 100500 FDA UDI
- Primary DI / UDI-DI
- 09413000095982 FDA UDI
- FDA Product Code
- HCC FDA UDI
- GMDN Term
- Psychophysiological biofeedback system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Psychophysiological biofeedback system
Axon 2 by Exsurgo Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Exsurgo Limited
Sources (1)
- FDA UDI 4ddb9e77-5b8a-4943-8061-fc4f30b538c9 36 fields · synced May 30, 2026