FDA.reportPublic FDA data

Tobii Dynavox

Primary DI
07340074601110
Brand
Tobii Dynavox
Company
TOBII DYNAVOX LLC
Model
I-16
Catalog number
12006977
Device description
"Speech Generating Device with Eye Tracking - 16"" screen."
Published
2019-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
07340074601110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340074601110073400746011107340074601110

GMDN Terms#

Term, Definition table
TermDefinition
Voice synthesizer/digitizerAn assistive device designed to deliver voice output based either in the reproduction of previously-recorded natural speech and/or on an electronic synthesized voice following a pre-established set of pronunciation rules. It typically consists of an electronic unit with a keyboard and screen; the keyboard may include letters, symbols, or both. The device is often customized to meet the user?s needs and is mostly used by patients with disabilities that partially or totally impair voice capabilities, including chronic progressive diseases.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-344-1778susie.peroni@tobiidynavox.com

Regulatory Flags#

DUNS number
119127942
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07340074602179Tobii DynavoxTD Pilot 27505632026-04-05
07340074602032Tobii DynavoxTD Navio Mini7505792024-09-06
07340074602056Tobii DynavoxTD Navio Midi7505802024-09-06
07340074602070Tobii DynavoxTD Navio Maxi7505812024-09-06
07340074602094Tobii DynavoxTD I-11010008002024-09-06
07340074602124Tobii DynavoxNGE60-TD5211002024-09-06
07340074601202Tobii DynavoxTDGG2120069392023-05-04
07340074601998Tobii DynavoxTD I-1310002542023-05-04
07340074602001Tobii DynavoxTD I-1610002552023-05-04
07340074601929Tobii DynavoxSC Tablet Mini113527 2022-09-01
07340074600267Tobii DynavoxI-12+ IS202016-09-09
07340074600274Tobii DynavoxI-15+ IS202016-09-09
07340074600304Tobii DynavoxT77504712016-09-09
07340074600328Tobii DynavoxI-12+ IS42016-09-09
07340074600335Tobii DynavoxI-15+ IS42016-09-09
07340074600397Tobii DynavoxIndi2017-04-15
07340074600410Tobii DynavoxI-110120048602017-10-06
07340074601042Tobii DynavoxIndi 77505182018-05-15
07340074601301Tobii DynavoxSC Tablet8007082018-08-27
07340074601318Tobii DynavoxSC Tablet8007092018-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840828196468RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-05-27
G783OSKOL20IrisbondIRISBOND CROWDBONDING SL.ILQ2025-08-01
00812324010319Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010326Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010333Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010340Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010357Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010364Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010371Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010388Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010395Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010401Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010418Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010425Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010432Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010449Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010456Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010463Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010470Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010487Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010494Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010500Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010517Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010524Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010531Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010548Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010555Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010562Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010579Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010586Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13