Happyneuron Cognitive Training
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Basic Information
- Brand Name
- Happyneuron Cognitive Training
- Primary DI
- 03665099000002
- Version / Model
- Version 1
- Company Name
- HAPPYNEURON
- Labeler DUNS
- 263821074
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-01
- Public Version
- 7
- Public Version Date
- 2025-11-20
- Public Version Status
- Update
- Public Device Record Key
- 6173a606-2354-4b11-b63f-a7d1f50fb5f6
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PTY | Computerized Cognitive Assessment Aid, Exempt | Neurology | 882.1470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63031 | Mental health/function therapeutic software, screen-viewed | A screen-based (non-virtual-reality) software program intended to be used with an off-the-shelf computer/smart device to help improve mental health/wellbeing (e.g., control effects of mood disorders, stress) and/or a cognitive function (e.g., concentration, memory, eye movement training to improve reading, speech) by providing a patient with on-screen interactive sessions. It may additionally be designed to assess cognition/mental health, set baselines, help manage pain, and will typically track development (i.e., interactive). It is not intended for kinesiology-based neuromuscular rehabilitation. It is intended to be used by the patient and may involve clinical assistance/recommendations. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03665099000002 | GS1 |