FDA.reportPublic FDA data

GoCheck

Primary DI
B43056000011100
Brand
GoCheck
Company
Gobiquity, Inc.
Model
Hearing Mobile App V1.1.0
Device description
Mobile Application for Hearing Screening
Published
2025-12-02
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
EWOAudiometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B43056000011100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tone audiometerAn electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone intensity and frequency either by a computer or manually, and displays/records the patient's responses, typically in the form of an audiogram. It may include a bone vibrator for direct inner-ear stimulation.

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

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
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
00810046707562Grason-StadlerDiagnostic Group LLCEWO2026-06-04
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
057117810041053000 Real EarAuditdata A/SEWO2026-01-23
057117810041363000 Real EarAuditdata A/SEWO2026-01-23
057117810041433000 Real EarAuditdata A/SEWO2026-01-23
057117810041503000 Real EarAuditdata A/SEWO2026-01-23
057117810041673000 Real EarAuditdata A/SEWO2026-01-23
057117810041743000 Real EarAuditdata A/SEWO2026-01-23
B43056000011110GoCheckGobiquity, Inc.EWO2026-01-09
05060753520090Tympa Otoscope SystemTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.EWO2025-11-19
05711781004204Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004211Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004228Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004235Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004242Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004259Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004266Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004280Measure by OtometricsAuditdata A/SEWO2025-11-14
05711117230833Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230840Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230857Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230864Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117245097Sanibel Supply A/SInteracoustics A/SEWO2025-08-07