FDA.reportPublic FDA data

Voice synthesizer/digitizer

Definition
An 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.
GUDID devices
364
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00816486020926PRC-SaltilloPRENTKE ROMICH COMPANYViaPro11.12020-06-01
00816486020933PRC-SaltilloPRENTKE ROMICH COMPANY19232-842020-06-01
00816486020940PRC-SaltilloPRENTKE ROMICH COMPANY19232-802020-06-01
00816486020957PRC-SaltilloPRENTKE ROMICH COMPANY19232-602020-06-01
00816486020964PRC-SaltilloPRENTKE ROMICH COMPANY19232-422020-06-01
00816486020971PRC-SaltilloPRENTKE ROMICH COMPANY19232-252020-06-01
00816486020988PRC-SaltilloPRENTKE ROMICH COMPANY19232-152020-06-01
00816486020995PRC-SaltilloPRENTKE ROMICH COMPANY192322020-06-01
00816486021206PRC-SaltilloPRENTKE ROMICH COMPANYVia™Air 102021-11-17
00816486021350ViaPRENTKE ROMICH COMPANYVM8.12023-01-09
00816486021398Via®MiniPRENTKE ROMICH COMPANY19663-152023-01-09
00816486021404Via®MiniPRENTKE ROMICH COMPANY19663-202023-01-09
00816486021411Via®MiniPRENTKE ROMICH COMPANY19663-252023-01-09
00816486021428Via®MiniPRENTKE ROMICH COMPANY19663-422023-01-09
00816486021435Via®MiniPRENTKE ROMICH COMPANY19663-602023-01-09
00816486021442Via®MiniPRENTKE ROMICH COMPANY19663-842023-01-09
00816486021459Via®MiniPRENTKE ROMICH COMPANY19662-252023-01-09
00816486021466Via®MiniPRENTKE ROMICH COMPANY19662-422023-01-27
00816486021572LAMP WFL Discover AppPRENTKE ROMICH COMPANYLAMP WFL Discover2025-10-13
00816486021626Unity AAC AppPRENTKE ROMICH COMPANYUnity AAC2025-10-13
00816486021695Via Pro 25 Loc TGPRENTKE ROMICH COMPANY19233-25-A2026-04-23
00816486021701Via Pro 42 Loc TGPRENTKE ROMICH COMPANY19233-42-A2026-04-23
00816486021718Via Pro 60 Loc TGPRENTKE ROMICH COMPANY19233-60-A2026-04-23
00816486021725Accent-800PRENTKE ROMICH COMPANY17348-KIT2026-04-22
00816486021732Accent-1000PRENTKE ROMICH COMPANY17345-KIT2026-04-22
00816486021749Accent-1400PRENTKE ROMICH COMPANY17342-KIT2026-04-22
00850041729237Grid Pad 13 with EvoTalk To ME Technologies, LLCEVO-KIT132025-10-24
00850041729244Grid Pad 16 with EvoTalk To ME Technologies, LLCEVO-KIT162025-10-24
00858526006750Accent 1000PRENTKE ROMICH COMPANYACN1000-402022-12-15
00860011903963G16Smartbox Assistive Technology Inc.GP16A-G162025-05-27
07340074602179Tobii DynavoxTOBII DYNAVOX LLCTD Pilot 22026-04-05
G783OSKOL20IrisbondIRISBOND CROWDBONDING SL.Oskol22025-08-01
00816486021640PRC-SaltilloPRENTKE ROMICH COMPANYPredictable App2026-03-10
00816486021633Unity Discover AppPRENTKE ROMICH COMPANYUnity2025-08-05
G783OSKOL21IrisbondIRISBOND CROWDBONDING SL.Oskol22025-08-01
00850041729206Grid Pad 16Talk To ME Technologies, LLCGP16A2025-04-02
00850041729213Grid Pad 16 Lumin-iTalk To ME Technologies, LLCLUMIN-I-KIT162025-04-02
00850041729220Grid Pad 16 VidaTalk To ME Technologies, LLCVIDA-KIT162025-04-02
B660RMNXL0Nuvo XLRM SPEECHRMNXL2025-02-28
B398PS060ProSlateFORBES REHAB SERVICES INCProSlate 62025-02-19
00816486021541PRC-SaltilloPRENTKE ROMICH COMPANYVia Nano 6.12025-02-06
00860011903970G10x SlimlineSmartbox Assistive Technology Inc.SS10E2025-01-14
00850041729190Grid Pad GoTalk To ME Technologies, LLC102024-12-02
00860011903932G10xSmartbox Assistive Technology Inc.GP10-G10x2024-11-27
00860011903949G15Smartbox Assistive Technology Inc.GP15A-G152024-10-21
00860011903956G10Smartbox Assistive Technology Inc.GP10A-G102024-10-21
07340074602032Tobii DynavoxTOBII DYNAVOX LLCTD Navio Mini2024-09-06
07340074602056Tobii DynavoxTOBII DYNAVOX LLCTD Navio Midi2024-09-06
07340074602070Tobii DynavoxTOBII DYNAVOX LLCTD Navio Maxi2024-09-06
07340074602094Tobii DynavoxTOBII DYNAVOX LLCTD I-1102024-09-06
07340074602124Tobii DynavoxTOBII DYNAVOX LLCNGE60-TD2024-09-06
00860011903901G13Smartbox Assistive Technology Inc.GP13A-G132024-03-20
00850041729176Grid Pad 13 Lumin-iTalk To ME Technologies, LLCLUMIN-I-KIT132024-03-15
00850041729183Grid Pad 13Talk To ME Technologies, LLCGP13A2024-03-15
00850041729169Grid Pad 13 VidaTalk To ME Technologies, LLCVIDA-KIT132024-03-14
00850041729145zuvoTalk To ME Technologies, LLC12 with Vida Go2024-02-05
00850041729152ZuvoTalk To ME Technologies, LLC16 with Vida Go2024-02-05
00816486021015SaltilloPRENTKE ROMICH COMPANYTouchChat App2023-11-08
00816486021022SaltilloPRENTKE ROMICH COMPANYTouchChat App2023-11-08
00816486021039SaltilloPRENTKE ROMICH COMPANYTouchChat App2023-11-08
00816486021053SaltilloPRENTKE ROMICH COMPANYTouchChat App2023-11-08
00816486021060PRCPRENTKE ROMICH COMPANYQuasselkiste App2023-11-08
00816486021077PRCPRENTKE ROMICH COMPANYLAMP WFL (UK) App2023-11-08
00816486021084PRCPRENTKE ROMICH COMPANYLAMP WFL App2023-11-08
00816486021183PRC-SaltilloPRENTKE ROMICH COMPANYDialogue App2023-11-08
00816486021237EloquencePRENTKE ROMICH COMPANYEloquence App2023-11-08
00816486021367PRC-SaltilloPRENTKE ROMICH COMPANYDiscover App2023-11-08
00816486021473NovaChatPRENTKE ROMICH COMPANY20066-422023-10-11
00816486021480NovaChatPRENTKE ROMICH COMPANY20066-252023-10-11
00816486021497NovaChatPRENTKE ROMICH COMPANY20066-602023-10-11
00858526006941NovaChatPRENTKE ROMICH COMPANY20062-152023-10-11
00858526006958NovaChatPRENTKE ROMICH COMPANY20062-202023-10-11
00858526006965NovaChatPRENTKE ROMICH COMPANY20062-252023-10-11
00858526006972NovaChatPRENTKE ROMICH COMPANY20062-422023-10-11
00858526006989NovaChatPRENTKE ROMICH COMPANY20062-602023-10-11
00858526006996NovaChatPRENTKE ROMICH COMPANY20062-842023-10-11
B925TP08EL80L8Smartbox Assistive Technology Inc.TP08E-L82023-09-26
B925TP10EL100L10.2Smartbox Assistive Technology Inc.TP10E-L102023-09-26
B925TP10HL100L10Smartbox Assistive Technology Inc.TP10H-L102023-09-26
B925TS08EL80L8 SlimlineSmartbox Assistive Technology Inc.TS08E-L82023-09-26