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

Related Records

Product Codes

CodeName
PTYComputerized Cognitive Assessment Aid, Exempt

Product Code Classifications

CodeDeviceSpecialtyClass
PTYComputerized Cognitive Assessment Aid, ExemptNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03665099000002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03665099000002036650990000023665099000002

GMDN Terms

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

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860013886127CNS Vital Signs VSCCNS Vital Signs, LLCPTY2025-09-01
05070002974673NeuroMotor PenMANUS NEURODYNAMICA LTDPTY2025-08-01
00860013886103CNS Vital Signs WebCNS Vital Signs, LLCPTY2025-07-07
00860013886110CNS Vital Signs LocalCNS Vital Signs, LLCPTY2025-07-07
00860013886134CNS Vital Signs CognitraxCNS Vital Signs, LLCPTY2025-07-07
00860000564045Cognivue ClarityCOGNIVUE, INC.PTY2025-06-12
00860000564052Cognivue ThriveCOGNIVUE, INC.PTY2025-06-12
00860011882022SPARK NeuroSpark Neuro Inc.PTY2025-05-01
G676NEUROFLEX0NeuroFlexSaccade Analytiques IncPTY2025-04-29
04262390860015neotivCareneotiv GmbHPTY2025-04-14
G134EPIO1NeuroCatch EPiONeuroCatch IncPTY2025-02-28
G134NCCPXS1NeuroCatch EEG CapNeuroCatch IncPTY2024-12-01
00860011464501CognigramCogstate Inc.PTY2024-08-24
00860011464518CognigramCogstate Inc.PTY2024-08-24
00860007318764Cognition Chronicle v2.1Qr8 Health IncPTY2024-07-22
B626200050Core Cognitive EvaluationLinus Health, Inc.PTY2024-06-05
00860007318788Chronicle Web v2.0Qr8 Health IncPTY2024-05-20
00860007318795Cognition Chronicle v2.0Qr8 Health IncPTY2024-05-20
00860011850922Cognition Snapshot+ v2.4Qr8 Health IncPTY2024-04-29
00860011850908MSPT v3.1.1Qr8 Health IncPTY2024-04-05
00860011850915MSPT Web v3.1.0Qr8 Health IncPTY2024-04-05
00195893329458MSPT Web v3.0Qr8 Health IncPTY2024-03-01
00195893702190MSPT v3.0Qr8 Health IncPTY2024-02-16
00860011154501BrainCheck AssessBraincheck, Inc.PTY2023-12-15
00860007318771Cognition Snapshot+ 2.3.0Qr8 Health IncPTY2023-11-01
00860009958104Cognitive Assessment Battery (CAB)® PROCognifit, Inc.PTY2023-08-14
G527GTDHIPALPRO01V1010HiPAL ProGT DIAGNOSTICS (UK) LIMITEDPTY2023-07-28
00860007318757Cognition Snapshot+ 2.2.0Qr8 Health IncPTY2023-05-22
00860009693401Speech Vitals - CognitionAural Analytics, Inc.PTY2022-12-15
00196852685837Speech Vitals - CognitionAural Analytics, Inc.PTY2022-11-07