Tobii Dynavox

GUDID 07340074600335

Speech Generating Device with Eyegaze (IS4) 15" screen

TOBII DYNAVOX LLC

Voice synthesizer/digitizer
Primary Device ID07340074600335
NIH Device Record Key5695fde7-78b8-4cb5-99f0-7928983bd087
Commercial Distribution StatusIn Commercial Distribution
Brand NameTobii Dynavox
Version Model NumberI-15+ IS4
Company DUNS119127942
Company NameTOBII DYNAVOX LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-344-1778
EmailSusie.peroni@tobiidynavox.com
Phone800-344-1778
EmailSusie.peroni@tobiidynavox.com
Phone800-344-1778
EmailSusie.peroni@tobiidynavox.com
Phone800-344-1778
EmailSusie.peroni@tobiidynavox.com
Phone800-344-1778
EmailSusie.peroni@tobiidynavox.com
Phone800-344-1778
EmailSusie.peroni@tobiidynavox.com
Phone800-344-1778
EmailSusie.peroni@tobiidynavox.com
Phone800-344-1778
EmailSusie.peroni@tobiidynavox.com
Phone800-344-1778
EmailSusie.peroni@tobiidynavox.com
Phone800-344-1778
EmailSusie.peroni@tobiidynavox.com
Phone800-344-1778
EmailSusie.peroni@tobiidynavox.com
Phone800-344-1778
EmailSusie.peroni@tobiidynavox.com
Phone800-344-1778
EmailSusie.peroni@tobiidynavox.com
Phone800-344-1778
EmailSusie.peroni@tobiidynavox.com
Phone800-344-1778
EmailSusie.peroni@tobiidynavox.com
Phone800-344-1778
EmailSusie.peroni@tobiidynavox.com
Phone800-344-1778
EmailSusie.peroni@tobiidynavox.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107340074600335 [Primary]

FDA Product Code

ILQSystem, Communication, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-09

On-Brand Devices [Tobii Dynavox]

07340074601479SC TABLET PRO, SGD, WITH SNAP + CORE FIRST, RASPBERRY SC/SPACE GRAY TABLET
07340074601462SC TABLET PRO, SGD, WITH SNAP + CORE FIRST, RASPBERRY SC/GOLD TABLET
07340074601455SC TABLET PRO, SGD, WITH SNAP + CORE FIRST, RASPBERRY SC/SILVER TABLET
07340074601448SC TABLET PRO, SGD, WITH SNAP + CORE FIRST, STEEL GRAY SC/SPACE GRAY TABLET
07340074601431SC TABLET PRO, SGD, WITH SNAP + CORE FIRST, STEEL GRAY SC/GOLD TABLET
07340074601424SC TABLET PRO, SGD, WITH SNAP + CORE FIRST, STEEL GRAY SC/SILVER TABLET
07340074601417SC TABLET PRO, SGD, WITH SNAP + CORE FIRST, TEAL BLUE SC/SPACE GRAY TABLET
07340074601400SC TABLET PRO, SGD, WITH SNAP + CORE FIRST, TEAL BLUE SC/GOLD TABLET
07340074601394SC TABLET PRO, SGD, WITH SNAP + CORE FIRST, TEAL BLUE SC/SILVER TABLET
07340074601387SC TABLET, SGD, WITH SNAP + CORE FIRST, RASPBERRY SC/SPACE GRAY TABLET
07340074601370SC TABLET, SGD, WITH SNAP + CORE FIRST, RASPBERRY SC/GOLD TABLET
07340074601363SC TABLET, SGD, WITH SNAP + CORE FIRST, RASPBERRY SC/SILVER TABLET
07340074601356SC TABLET, SGD, WITH SNAP + CORE FIRST, STEEL GRAY SC/SPACE GRAY TABLET
07340074601349SC TABLET, SGD, WITH SNAP + CORE FIRST, STEEL GRAY SC/GOLD TABLET
07340074601332SC TABLET, SGD, WITH SNAP + CORE FIRST, STEEL GRAY SC/SILVER TABLET
07340074601325SC TABLET, SGD, WITH SNAP + CORE FIRST, TEAL BLUE SC/SPACE GRAY TABLET
07340074601318SC TABLET, SGD, WITH SNAP + CORE FIRST, TEAL BLUE SC/GOLD TABLET
07340074601301SC TABLET, SGD, WITH SNAP + CORE FIRST, TEAL BLUE SC/SILVER TABLET
07340074601141A Speech Generating Device with Eyegaze access. A deployed Surface Pro Windows use by people wi
07340074601042Speech Generating Device with a 7" screen on Windows platform. Tobii Dynavox software includes
07340074600410Speech Generating Device with a 10" in touch screen. Tablet style unit, water resistant and dur
07340074600397Small, lightweight portable Speech Generating Device with touch screen, Snap or Communicator Sof
07340074600335Speech Generating Device with Eyegaze (IS4) 15" screen
07340074600328Speech Generating Device with Eyegaze (IS 4) 12" Screen
07340074600304Speech Generating Device with 7" screen
07340074600298Speech Generating Device with 15" screen
07340074600281Speech Generating Device with 10" screen
07340074600274Speech Generating Device with Eyegaze (IS 20) 15" Screen
07340074600267Speech Generating Device with Eyegaze (IS 20)
07340074601516Speech Generating Device with Eye Tracking - 16" screen.
07340074601509Speech Generating Device with Eye tracking capability - 13" screen size
07340074601110Speech Generating Device with Eye Tracking - 16" screen.
07340074601035Speech Generating Device with Eye tracking capability - 13" screen size
07340074601806SC TABLET, SGD, WITH SNAP + CORE FIRST, for 10.2" iPad
07340074601769TD Pilot, Speech Generating Device (SGD) with Eye tracking Capability, for iPad Pro
07340074601714TD I-110 Portable Speech Generating Device designed for people who can not speak due to injury,
07340074601929SC TABLET MINI, SGD, WITH TDSNAP FOR iOS and iPad Mini. Small portable speech device for people
07340074602001Speech Generating Device with Eye Tracking - 16" screen.
07340074601998Speech Generating Device with Eye tracking capability - 13" screen size
07340074601202Battery Pack for I-13, I-16, TD I-13 or TD I-16. Not integral, can be changed by customer.
07340074602124USB-C AC Adaptor for Tobii Dynavox Devices. Medical grade/certified to IEC 60601 and UL Approve
07340074602094TD I-110 (2nd Generation) Portable Speech Generating Device designed for people who can not spea
07340074602070TD Navio Mini, Model: TDNL1, is a Speech Generating Device (aka AAC Device), Powered Communicati
07340074602056TD Navio Midi, Model: TDNM1, is a Speech Generating Device (aka AAC Device), Powered Communicati
07340074602032TD Navio Mini, Model: TDNS1, is a Speech Generating Device (aka AAC Device), Powered Communicati

Trademark Results [Tobii Dynavox]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TOBII DYNAVOX
TOBII DYNAVOX
97700256 not registered Live/Pending
Tobii Dynavox AB
2022-12-01
TOBII DYNAVOX
TOBII DYNAVOX
88473395 not registered Live/Pending
Tobii AB
2019-06-14

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.