FDA.reportPublic FDA data

Manifold Vision Meter

Primary DI
00850067216018
Brand
Manifold Vision Meter
Company
Adaptive Sensory Technology, Inc.
Model
001.000.005
Published
2025-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QTODigital Visual Acuity Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTODigital Visual Acuity TestOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850067216018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850067216018008500672160188500672160180850067216018

GMDN Terms#

Term, Definition table
TermDefinition
Visual acuity projectorA mains electricity (AC-powered) ophthalmic device intended to project an image on a screen to test visual acuity. The images typically include block letters (Snellen chart) and/or other symbols (e.g., recognizable objects used for children who cannot read) viewed in gradually decreasing size. They are typically identified according to the distance at which they are ordinarily visible (normally 6 metres or 20 feet).

Regulatory Flags#

DUNS number
067936644
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850067216025Manifold Vision Meter001.000.005 (with TÜV SÜD safety mark)2026-05-21
00850067216032Manifold Vision Meter001.000.004 (with TÜV SÜD safety mark)2026-05-21
00850067216001Manifold Vision Meter001.000.0042025-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850067216025Manifold Vision MeterAdaptive Sensory Technology, Inc.QTO2026-05-21
00850067216032Manifold Vision MeterAdaptive Sensory Technology, Inc.QTO2026-05-21
00850067216001Manifold Vision MeterAdaptive Sensory Technology, Inc.QTO2025-10-07
00850040295818OCULUS Easyfield VRThe Hilsinger Company Parent LLCQTO2023-12-25
07290018993408MyRx Visual Acuity 6 OVER 6 VISION LTDQTO2023-08-30
00853569007146PalmScan VS2000Micro Medical Devices, Inc.QTO2023-08-16
G506DG010AMA Optics Digital Vision TestAMA Optics, Inc.QTO2023-08-01
00850038376000VDAPVisibly, Inc.QTO2022-09-19
00850040295238M&S Technologies ACUITYexThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295566M&S Technologies Smart System® 20/20The Hilsinger Company Parent LLCQTO2022-07-06
00850040295573M&S Technologies Smart System® PC-PlusThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295597M&S Technologies Smart System® 20/20 TabletThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295016M&S Technologies VisiChart® Acuity ChartThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295122M&S Technologies Smart System® Virtual Reality Headset SystemThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295139M&S Technologies Clinical Trial Suite®The Hilsinger Company Parent LLCQTO2022-07-06
00850040295214M&S Technologies Melbourne Rapid Fields Device In-ClinicThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295351M&S Technologies ACUITYexThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295559M&S Technologies Smart System® StandardThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295047M&S Technologies Smart System® 20/20The Hilsinger Company Parent LLCQTO2022-07-06
00850040295191M&S Technologies Smart System® PC-PlusThe Hilsinger Company Parent LLCQTO2022-07-06
00850040295108M&S Technologies Smart System® 20/20 TabletThe Hilsinger Company Parent LLCQTO2022-07-06