FDA.reportPublic FDA data

SPEAX Digital Communicator

Primary DI
B792FGN007
Brand
SPEAX Digital Communicator
Company
ATAIA INC.
Model
FGN-007
Catalog number
FGN007
Device description
Digital Communicator for use with the SPEAX Communication System
Published
2021-07-05
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
B792FGN007PrimaryHIBCC0

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-20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-711-5057contact@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
B792FGN001SPEAX CommunicatorFGN-001FGN0012020-03-09
B792FGN006SPEAX Trial PackageFGN-006FGN0062020-03-09
B792FGN004SPEAX Starter PackageFGN-004FGN0042020-03-09
B792FGN003SPEAX PatchFGN-002FGN0022020-03-09

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