FDA.reportPublic FDA data

GoCheck Kids

Primary DI
B430GCKNOK4630
Brand
GoCheck Kids
Company
Gobiquity, Inc.
Model
Nokia 4.6.3
Catalog number
GCKNOK463
Device description
GoCheck Kids Native Software Application for Nokia.
Published
2017-06-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MMFPhotorefractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMFPhotorefractorOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B430GCKNOK44600PreviousHIBCC0
B430GCKNOK4630PrimaryHIBCC0

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).

Contacts#

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

Regulatory Flags#

DUNS number
035145840
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B430GCKIOS5430GoCheck KidsiPhone 5.4.32023-06-15
B43050085600GoCheck KidsVision Mobile Application Version 5.6.02025-10-22
B430GCKNOK44290LGoCheck KidsNokia 4.4.292017-02-11
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
B43071000020GoCheck MultiScreeneri7 Plus2024-09-23
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
B43050085700GoCheck KidsGobiquity, Inc.MMF2026-01-09
B43071000030GoCheck MultiScreenerGobiquity, Inc.MMF2025-11-19
B43050085610GoCheck KidsGobiquity, Inc.MMF2025-11-04
B43050085600GoCheck KidsGobiquity, Inc.MMF2025-10-22
B43050085500GoCheck KidsGobiquity, Inc.MMF2025-03-20
B43071000020GoCheck MultiScreenerGobiquity, Inc.MMF2024-09-23
B43050085440GoCheck KidsGobiquity, Inc.MMF2024-07-26
B43071000010GoCheck KidsGobiquity, Inc.MMF2024-07-26
B43060030010GoCheck KidsGobiquity, Inc.MMF2023-07-06
B430GCKIOS5430GoCheck KidsGobiquity, Inc.MMF2023-06-15
B430GCKNOK44600GoCheck KidsGobiquity, Inc.MMF2017-02-27
B430GCKNOK44290LGoCheck KidsGobiquity, Inc.MMF2017-02-11
B430GCKNOK44360GoCheck KidsGobiquity, Inc.MMF2016-12-30