SPEAX Patch for Home Use

Primary DI
B792FGN010
Brand
SPEAX Patch for Home Use
Company
ATAIA INC.
Model
FGN-010
Catalog number
FGN010
Device description
Patch for use with the SPEAX Digital Communication System for Home Use
Published
2022-01-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
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
B792FGN014PackageHIBCC5In Commercial Distribution
B792FGN015PackageHIBCC10In Commercial Distribution
B792FGN016PackageHIBCC1In Commercial Distribution
B792FGN010PrimaryHIBCC0

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.

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
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
B792FGN004SPEAX Starter PackageFGN-004FGN0042020-03-09
B792FGN003SPEAX PatchFGN-002FGN0022020-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00812324010562Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010579Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
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