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
408
Last updated
2026-11-01 02:55:05

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00816486021589Via™ Pro 11PRENTKE ROMICH COMPANYViaPro11.32026-10-21
00816486021602Genesis™ 13PRENTKE ROMICH COMPANYGNS13.12026-10-21
00816486021619Genesis™ 16PRENTKE ROMICH COMPANYGNS16.12026-10-21
00816486021664Genesis Eye Tracker™PRENTKE ROMICH COMPANYGNS-ET2026-10-21
00816486021671Genesis™ 13 CHG EXTPRENTKE ROMICH COMPANY2050092026-10-21
00816486021688Genesis™ 16 CHG EXTPRENTKE ROMICH COMPANY2050122026-10-21
00816486021763Genesis™ 13 144 Location KeyGuardPRENTKE ROMICH COMPANY3004062026-10-21
00816486021770Genesis™ 13 45 Location KeyGuardPRENTKE ROMICH COMPANY3004072026-10-21
00816486021787Genesis™ 13 60 Location KeyGuardPRENTKE ROMICH COMPANY3004082026-10-21
00816486021794Genesis™ 13 84 Location KeyGuardPRENTKE ROMICH COMPANY3004092026-10-21
00816486021800Genesis™ 13 15 Location KeyGuardPRENTKE ROMICH COMPANY3004102026-10-21
00816486021817Genesis™ 13 28 Location KeyGuardPRENTKE ROMICH COMPANY3004112026-10-21
00816486021824Genesis™ 13 36 Location KeyGuardPRENTKE ROMICH COMPANY3004122026-10-21
00816486021831Genesis™ 13 8 Location KeyGuardPRENTKE ROMICH COMPANY3004132026-10-21
00816486021848Genesis™ 13 15 Location TouchGuidePRENTKE ROMICH COMPANY3004142026-10-21
00816486021855Genesis™ 13 28 Location TouchGuidePRENTKE ROMICH COMPANY3004152026-10-21
00816486021862Genesis™ 13 36 Location TouchGuidePRENTKE ROMICH COMPANY3004162026-10-21
00816486021879Genesis™ 13 45 Location TouchGuidePRENTKE ROMICH COMPANY3004172026-10-21
00816486021886Genesis™ 13 60 Location TouchGuidePRENTKE ROMICH COMPANY3004182026-10-21
00816486021893Genesis™ 13 8 Location TouchGuidePRENTKE ROMICH COMPANY3004192026-10-21
00816486021909Genesis™ 13 84 Location TouchGuidePRENTKE ROMICH COMPANY3004202026-10-21
00816486021916Genesis™ 13 144 Location TouchGuidePRENTKE ROMICH COMPANY3004212026-10-21
00816486021923Genesis™ 16 144 Location KeyGuardPRENTKE ROMICH COMPANY3004252026-10-21
00816486021930Genesis™ 16 45 Location KeyGuardPRENTKE ROMICH COMPANY3004262026-10-21
00816486021947Genesis™ 16 60 Location KeyGuardPRENTKE ROMICH COMPANY3004272026-10-21
00816486021954Genesis™ 16 84 Location KeyGuardPRENTKE ROMICH COMPANY3004282026-10-21
00816486021961Genesis™ 16 15 Location KeyGuardPRENTKE ROMICH COMPANY3004292026-10-21
00816486021978Genesis™ 16 28 Location KeyGuardPRENTKE ROMICH COMPANY3004302026-10-21
00816486021985Genesis™ 16 36 Location KeyGuardPRENTKE ROMICH COMPANY3004312026-10-21
00816486021992Genesis™ 16 8 Location KeyGuardPRENTKE ROMICH COMPANY3004322026-10-21
00816486022005Genesis™ 16 15 Location TouchGuidePRENTKE ROMICH COMPANY3004332026-10-21
00816486022012Genesis™ 16 28 Location TouchGuidePRENTKE ROMICH COMPANY3004342026-10-21
00816486022029Genesis™ 16 36 Location TouchGuidePRENTKE ROMICH COMPANY3004352026-10-21
00816486022036Genesis™ 16 45 Location TouchGuidePRENTKE ROMICH COMPANY3004362026-10-21
00816486022043Genesis™ 16 60 Location TouchGuidePRENTKE ROMICH COMPANY3004372026-10-21
00816486022050Genesis™ 16 8 Location TouchGuidePRENTKE ROMICH COMPANY3004382026-10-21
00816486022067Genesis™ 16 84 Location TouchGuidePRENTKE ROMICH COMPANY3004392026-10-21
00816486022074Genesis™ 16 144 Location TouchGuidePRENTKE ROMICH COMPANY3004402026-10-21
00816486022081Genesis™ Quick Access Button KeyGuardPRENTKE ROMICH COMPANY3004612026-10-21
00816486022098Genesis™ 13 Solid Location KeyGuardPRENTKE ROMICH COMPANY3004682026-10-21
00816486022104Genesis™ 13 Eval KeyGuardPRENTKE ROMICH COMPANY3004692026-10-21
00816486022111Genesis™ 16 Solid KeyGuardPRENTKE ROMICH COMPANY3004702026-10-21
00816486022128Genesis™ 16 Eval KeyGuardPRENTKE ROMICH COMPANY3004712026-10-21
00816486022135Genesis Head Tracker™PRENTKE ROMICH COMPANYGNS-HT2026-10-21
00850041729046zuvoTalk To ME Technologies, LLC102022-08-25
00850041729053zuvoTalk To ME Technologies, LLC122022-08-24
00850041729060zuvoTalk To ME Technologies, LLC162022-08-24
00850041729077zuvoTalk To ME Technologies, LLC12 with eyespeak2022-08-24
00850041729084zuvoTalk To ME Technologies, LLC16 with eyespeak2022-08-24
00850041729091zuvoTalk To ME Technologies, LLC12 with eyespeak inspo2022-08-24
00850041729107zuvoTalk To ME Technologies, LLC16 with eyespeak inspo2022-08-24
00850041729145zuvoTalk To ME Technologies, LLC12 with Vida Go2024-02-05
00850041729152ZuvoTalk To ME Technologies, LLC16 with Vida Go2024-02-05
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