FDA.reportPublic FDA data

T.O.V.A.

Primary DI
00862290000326
Brand
T.O.V.A.
Company
TOVA COMPANY, THE
Model
Software
Device description
The Test of Variables of Attention (T.O.V.A.) software is a computerized assessment of attention and inhibitory control that runs on most Windows and Mac-based computers. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
Published
2020-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
K173915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173915000Test of Variables of Attention (T.O.V.A.)The Tova Company2018-03-22LQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862290000326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862290000326008622900003268622900003260862290000326

GMDN Terms#

Term, Definition table
TermDefinition
Cognitive assessment softwareA software program intended to be used to assess cognitive function (e.g., attention/concentration, memory) and/or to assist early detection/diagnosis of mild cognitive impairment or dementia, using cognitive tests in combination with patient demographic data. The tests are completed by the patient on an off-the-shelf computer/tablet/smartphone and test results are intended to be reviewed by a medical specialist and/or used for longitudinal analysis. It is not intended for real-time home-monitoring of dementia patients.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
562.594.7700info@tovatest.com

Regulatory Flags#

DUNS number
174718481
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862290000302T.O.V.A.USB Device2020-01-02
00862290000319T.O.V.A.Microswitch2020-01-02
00862290000333T.O.V.A.Kit2020-01-02

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
00860011067641DynavisionDynavision 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
00862290000333T.O.V.A.TOVA COMPANY, THELQD2020-01-02