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 patientssuffering from cognitive impairments linked to chronic diseases. Two programs have been designed so fartargeting 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, ExecutiveFunctions and Visual-Spatial Skills). Coaching features guide the users through the exercises, adapt thedifficulty 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

Product Codes#

Code, Name table
CodeName
PTYComputerized Cognitive Assessment Aid, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTYComputerized Cognitive Assessment Aid, ExemptNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665099000002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665099000002036650990000023665099000002

GMDN Terms#

Term, Definition table
TermDefinition
Cognitive therapy softwareA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
263821074
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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