Home Vision Monitor®

Primary DI
00860004152705
Brand
Home Vision Monitor®
Company
VITAL ART AND SCIENCE, LLC
Model
Model 0005
Device description
The Home Vision Monitor® Model 0005 is a vision function test provided as a downloadable app on to the user’s supplied cell phone or tablet. The Home Vision Monitor® Model 0005 implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home. If a significant worsening of vision function is detected the physician will be notified and provided access to the vision self-test results so that they can decide whether the patient needs to be seen sooner than their next already scheduled appointment.
Published
2020-08-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HOQGrid, Amsler

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOQGrid, AmslerOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143211000myVision Track Model 005Vital Art and Science Incorporated2015-03-20HOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860004152705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860004152705008600041527058600041527050860004152705

GMDN Terms#

Term, Definition table
TermDefinition
Vision testing/training chartAn ophthalmic chart or card printed with various symbols (e.g., letters, pictures or dots) intended to be used for testing visual acuity (e.g., Snellen chart) or testing and/or training accommodation and/or convergence or other amenable ophthalmic functions. The chart/card may be held in front of the patient or placed on a table or wall and may have specific user instructions depending on specific use. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-486-3937support@myvisiontrack.com

Regulatory Flags#

DUNS number
782794213
Device count
1

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547451338338INAMIINAMI & CO., LTD.HOQ2025-12-19
04547451328650INAMIINAMI & CO., LTD.HOQ2023-07-27
EOMA32120AlleyeOCULOCARE medical AGHOQ2023-05-15