FDA.reportPublic FDA data

SPEAX Starter Package

Primary DI
B792FGN004
Brand
SPEAX Starter Package
Company
ATAIA INC.
Model
FGN-004
Catalog number
FGN004
Device description
The Starter Package for the SPEAX Communication System, including 5 Communicators and 30 Patches
Published
2020-03-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILQSystem, Communication, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILQSystem, Communication, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B792FGN004PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Voice amplification systemAn assembly of battery-powered, personal-worn, devices designed to amplify the loudness of the voice of a person with reduced vocal capacity (e.g., due to impairment of throat or chest muscles, partial paralysis of vocal cords, diminished lung capacity). It typically includes a dedicated microphone, an electronic amplifier, and a loudspeaker. Assemblies with special adaptors that are intended for use with an artificial larynx, a transoesophageal puncture tube, and/or other prostheses or implants are available. Some amplifiers are available as an integral part of an artificial larynx.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8557115057contact@ataiamedical.com

Regulatory Flags#

DUNS number
117116534
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B792FGN002SPEAX PatchFGN-002FGN0022020-03-09
B792FGN010SPEAX Patch for Home UseFGN-010FGN0102022-01-26
B792FGN011SPEAX Digital Communication System for Home UseFGN-011FGN0112022-01-26
B792FGN009SPEAX Digital Communicator Subscription PackageFGN-009FGN0092022-01-20
B792FGN008SPEAX Digital Communicator Trial PackageFGN-008FGN0082021-10-08
B792FGN007SPEAX Digital CommunicatorFGN-007FGN0072021-07-05
B792FGN001SPEAX CommunicatorFGN-001FGN0012020-03-09
B792FGN006SPEAX Trial PackageFGN-006FGN0062020-03-09
B792FGN003SPEAX PatchFGN-002FGN0022020-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816486021589Via™ Pro 11PRENTKE ROMICH COMPANYILQ2026-10-21
00816486021602Genesis™ 13PRENTKE ROMICH COMPANYILQ2026-10-21
00816486021619Genesis™ 16PRENTKE ROMICH COMPANYILQ2026-10-21
00816486021664Genesis Eye Tracker™PRENTKE ROMICH COMPANYILQ2026-10-21
00816486021671Genesis™ 13 CHG EXTPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021688Genesis™ 16 CHG EXTPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021763Genesis™ 13 144 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021770Genesis™ 13 45 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021787Genesis™ 13 60 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021794Genesis™ 13 84 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021800Genesis™ 13 15 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021817Genesis™ 13 28 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021824Genesis™ 13 36 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021831Genesis™ 13 8 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021848Genesis™ 13 15 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021855Genesis™ 13 28 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021862Genesis™ 13 36 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021879Genesis™ 13 45 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021886Genesis™ 13 60 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021893Genesis™ 13 8 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021909Genesis™ 13 84 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021916Genesis™ 13 144 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021923Genesis™ 16 144 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021930Genesis™ 16 45 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021947Genesis™ 16 60 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021954Genesis™ 16 84 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021961Genesis™ 16 15 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021978Genesis™ 16 28 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021985Genesis™ 16 36 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021992Genesis™ 16 8 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21