Happyneuron Cognitive Training
- Primary DI
- 03665099000002
- Brand
- Happyneuron Cognitive Training
- Company
- HAPPYNEURON
- Model
- Version 1
- 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.
- Published
- 2018-04-01
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| PTY | Computerized Cognitive Assessment Aid, Exempt |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| PTY | Computerized Cognitive Assessment Aid, Exempt | Neurology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 03665099000002 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 03665099000002 | 03665099000002 | 3665099000002 |
GMDN Terms
| Term | Definition |
|---|
| Cognitive therapy software | A software program intended to be used with an off-the-shelf computer/tablet/smartphone to help improve a cognitive function (e.g., attention/concentration, memory, eye movement training to improve reading ability) by providing a patient with on-screen interactive sessions (e.g., text for audible reading, stimulating game-like activities); it is not intended for kinesiology-based neuromuscular rehabilitation. It may additionally be designed to screen for cognitive disorders, set baselines, and will typically show development (i.e., interactive). It is intended to be used at home, school, and in clinical settings. |
Regulatory Flags
- DUNS number
- 263821074
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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