FDA.reportPublic FDA data

Dynavision

Primary DI
00860011067641
Brand
Dynavision
Company
Dynavision Global Holdings, LLC
Model
D2 220v with Mobile Stand
Device description
Attention Task Performance Recorder
Published
2024-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LQDRecorder, Attention Task Performance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQDRecorder, Attention Task PerformanceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K911938000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911938000DYNAVISION 2000Performance Ent.1991-08-02LQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011067641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011067641008600110676418600110676410860011067641

GMDN Terms#

Term, Definition table
TermDefinition
Reaction trainerAn electrically-powered device intended to assess and train sensory-motor integration (e.g., visual reaction time, eye-hand coordination) and peripheral awareness for the purposes of neurorehabilitation as well as athletic and military performance improvement. It is in the form of an upright board (e.g., touchscreen) with a number of light-up buttons; the user is instructed to focus on the screen and press the buttons as they are illuminated.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079220528
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011067610DynavisionD2 110v2024-06-10
00860011067627DynavisionD2 110v with Mobile Stand2024-06-10
00860011067634DynavisionD2 220v2024-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011067610DynavisionDynavision Global Holdings, LLCLQD2024-06-10
00860011067627DynavisionDynavision Global Holdings, LLCLQD2024-06-10
00860011067634DynavisionDynavision Global Holdings, LLCLQD2024-06-10
00860011042105DANA™Anthrotronix, Inc.LQD2023-10-09
07350103930012QbCheckQbtech ABLQD2023-06-14
07350103930067QbTestQbtech ABLQD2023-06-14
00862290000302T.O.V.A.TOVA COMPANY, THELQD2020-01-02
00862290000319T.O.V.A.TOVA COMPANY, THELQD2020-01-02
00862290000326T.O.V.A.TOVA COMPANY, THELQD2020-01-02
00862290000333T.O.V.A.TOVA COMPANY, THELQD2020-01-02