Identity
- Trade Name
- Happyneuron Cognitive Training FDA UDI
- Generic Name
- Mental health/function therapeutic software, screen-viewed FDA UDI
- Device Name
- The HappyNeuron Cognitive Training provides users with a program that is designed to be adapted for patients suffering from cognitive impairments linked to chronic diseases. Two programs have been designed so far targeting specific conditions: Multiple Sclerosis and Rheumatoid Arthritis. The cognitive training is a combination of scheduled workouts and on-demand complementary exercises. It contains computerized exercises that stimulate cognitive abilities (Memory, Attention, Language, Executive Functions and Visual-Spatial Skills). Coaching features guide the users through the exercises, adapt the difficulty settings dynamically, and follow-up on performance. FDA UDI
- Model / Reference
- Version 1 FDA UDI
- Description
- The HappyNeuron Cognitive Training provides users with a program that is designed to be adapted for patients suffering from cognitive impairments linked to chronic diseases. Two programs have been designed so far targeting specific conditions: Multiple Sclerosis and Rheumatoid Arthritis. The cognitive training is a combination of scheduled workouts and on-demand complementary exercises. It contains computerized exercises that stimulate cognitive abilities (Memory, Attention, Language, Executive Functions and Visual-Spatial Skills). Coaching features guide the users through the exercises, adapt the difficulty settings dynamically, and follow-up on performance. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03665099000002 FDA UDI
- FDA Product Code
- PTY FDA UDI
- GMDN Term
- Mental health/function therapeutic software, screen-viewed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1470 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mental health/function therapeutic software, screen-viewed
Happyneuron Cognitive Training by Happyneuron — 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
- Happyneuron
Sources (1)
- FDA UDI 6173a606-2354-4b11-b63f-a7d1f50fb5f6 33 fields · synced May 30, 2026