FDA.reportPublic FDA data

GoCheck MultiScreener

Primary DI
B43071000020
Brand
GoCheck MultiScreener
Company
Gobiquity, Inc.
Model
i7 Plus
Device description
GoCheck i7P MultiScreener Finished Device Assembly
Published
2024-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EWOAudiometer
HKORefractometer, Ophthalmic
HOXChart, Visual Acuity
MMFPhotorefractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2
HKORefractometer, OphthalmicOphthalmic1
HOXChart, Visual AcuityOphthalmic1
MMFPhotorefractorOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B43071000020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
External ocular measurement cameraA hand-held, battery-powered, optical device intended for digital image capture and analysis of the external ocular anatomy to assist in the diagnosis of ophthalmic abnormalities (e.g., ptosis, strabismus, glaucoma); it is not intended to capture images of the fundus. It consists of a digital camera which includes software intended to take specific ocular measurements (e.g., pupil diameter, horizontal visible iris diameter, margin reflex difference, interpupillary distance, strabismus angle).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-633-9243support@gocheckkids.com

Regulatory Flags#

DUNS number
035145840
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B43061000100GoCheck Audiometric Headphone AssemblySennheiser HD280 Pro for i152026-06-02
B430GCKIOS5430GoCheck KidsiPhone 5.4.32023-06-15
B43050085600GoCheck KidsVision Mobile Application Version 5.6.02025-10-22
B430GCKNOK44290LGoCheck KidsNokia 4.4.292017-02-11
B430GCKNOK4630GoCheck KidsNokia 4.6.3GCKNOK4632017-06-06
B43071000030GoCheck MultiScreeneri15 Pro2025-11-19
B43050085700GoCheck KidsVision Mobile Application Version 5.7.02026-01-09
B43056000011110GoCheckHearing Mobile App V1.1.12026-01-09
B43050085610GoCheck KidsVision Mobile Application Version 5.6.12025-11-04
B43056000011100GoCheckHearing Mobile App V1.1.02025-12-02
B43050085500GoCheck KidsVision Mobile Application Version 5.5.02025-03-20
B43056000011000GoCheckHearing Mobile App V1.0.02024-09-23
B43061000060GoCheck Audiometric Headphone AssemblySennheiser HD280 Pro2024-09-23
B43050085440GoCheck KidsMobile Application Version 5.4.42024-07-26
B43071000010GoCheck KidsV5 i15 PFC2024-07-26
B43060030010GoCheck KidsV5 i7 PFC2023-07-06
B430GCKNOK44360GoCheck KidsNokia 4.4.362016-12-30
B430GCKNOK44600GoCheck KidsNokia 4.4.60GCKNOK2017-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810046707562Grason-StadlerDiagnostic Group LLCEWO2026-06-04
06972039971092MOPTIMShenzhen CERTAINN Technology Co., Ltd.HKO2026-06-03
05745000311064OscillaOscilla A/SEWO2026-05-29
05745000311095OscillaOscilla A/SEWO2026-05-29
05745000311156OscillaOscilla A/SEWO2026-05-29
05745000311163OscillaOscilla A/SEWO2026-05-29
05745000311187OscillaOscilla A/SEWO2026-05-29
05745000311200OscillaOscilla A/SEWO2026-05-29
00810046707180Grason-StadlerDiagnostic Group LLCEWO2026-04-06
B43050085700GoCheck KidsGobiquity, Inc.HKO2026-01-09
B43050085700GoCheck KidsGobiquity, Inc.HOX2026-01-09
04987669204610Open-field Refraction SystemNIDEK CO.,LTD.HOX2026-01-08
04987669204917Open-field Refraction SystemNIDEK CO.,LTD.HOX2026-01-08
04560126269188AUTO KERATO-REFRACTOMETER KR-1TOPCON CORPORATIONHKO2025-11-21
08800019601074Visual Acuity Chart System HDC-100Huvitz Co., Ltd.HOX2025-11-19
05060753520090Tympa Otoscope SystemTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.MMF2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.HOX2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.EWO2025-11-19
B43050085610GoCheck KidsGobiquity, Inc.HOX2025-11-04
B43050085610GoCheck KidsGobiquity, Inc.HKO2025-11-04
04560126269140AUTO KERATO-REFRACTOMETER KR-800TOPCON CORPORATIONHKO2025-10-31
04560126269164AUTO REFRACTOMETER RM-800TOPCON CORPORATIONHKO2025-10-31
B43050085600GoCheck KidsGobiquity, Inc.HKO2025-10-22
B43050085600GoCheck KidsGobiquity, Inc.HOX2025-10-22
00860014277528S4Optik REF-K2000Lombart Brothers, Inc.HKO2025-10-18
04540008310030RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310320RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310436RexxamREXXAM CO., LTD.HKO2025-10-17
04540008310443RexxamREXXAM CO., LTD.HKO2025-10-17