FDA.reportPublic FDA data

Assistive speech generator

Definition
An electrically-powered device designed to facilitate communication by a patient with a disability and/or cognitive impairment by providing buttons with images that when pressed produce audible pre-recorded words or phrases associated with the images. It is a unit with a set of buttons/keyboard displaying symbols/pictures, a recording function, and a speaker. It is intended for use both in the home and healthcare facility.
GUDID devices
40
Last updated
2025-07-04 20:31:40

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850011150344BIG Candy Corn 2Ablenet, Inc.100000772025-06-26
00850011150382Specs ICAblenet, Inc.100001142025-06-26
00850011150399Buddy Button ICAblenet, Inc.100001152025-06-26
00850011150481QuickTalker FreestyleAblenet, Inc.100001292025-06-18
00850011150467QuickTalker Freestyle MiniAblenet, Inc.100001272025-06-17
00850011150443QuickTalker Freestyle MiniAblenet, Inc.100001252025-05-15
G549CLASSIC0EXPRESSIONRcs Management CorpCLASSIC2024-11-21
G549MICRO0EXPRESSIONRcs Management CorpMICRO2024-11-21
G549MINI0EXPRESSIONRcs Management CorpMINI2024-11-21
G549SUPREME0EXPRESSIONRcs Management CorpSUPREME2024-11-21
G549ULTRA0EXPRESSIONRcs Management CorpULTRA2024-11-21
G549MK2K3LLA0APPLERcs Management CorpMK2K3LL/A2024-04-12
G549MK7M3LLA0APPLERcs Management CorpMK7M3LL/A2024-04-12
G549MNXD3LLA0APPLERcs Management CorpMNXD3LL/A2024-04-12
G549MNXP3LLA0APPLERcs Management CorpMNXP3LL/A2024-04-12
G549MPQ03LLA0APPLERcs Management CorpMPQ03LL/A2024-04-12
G549MPQ83LLA0APPLERcs Management CorpMPQ83LL/A2024-04-12
G549MQ3R3LLA0APPLERcs Management CorpMQ3R3LL/A2024-04-12
G549MTXR3LLA0APPLERcs Management CorpMTXR3LL/A2024-04-12
G549S31000010MICROSOFTRcs Management CorpS31-000012024-04-12
G549XHU000010MICROSOFTRcs Management CorpXHU-000012024-04-12
00850055523005UbiDuoS-Comm, Inc.UbiDuo 3 SGD2023-10-17
00850055523012UbiDuoS-Comm, Inc.UbiDuo 3 Wireless2023-10-17
00850055523029UbiDuoS-Comm, Inc.UbiDuo 3 Wired2023-10-17
00850055523036UbiDuoS-Comm, Inc.UbiDuo 3 TTS12023-10-17
00850055523043UbiDuoS-Comm, Inc.UbiDuo 3 TTS22023-10-17
00850011150283QuickTalker FreestyleAblenet, Inc.700001172023-06-23
00850011150290QuickTalker Freestyle MiniAblenet, Inc.700001192023-06-23
00186648000524TalkingBrix 2Ablenet, Inc.100000322023-06-21
00186648000531iTalk4Ablenet, Inc.100000282023-06-21
00186648000548SuperTalker FeatherTouchAblenet, Inc.100000312023-06-21
00186648000791QuickTalker FT 7Ablenet, Inc.100000362023-06-21
00186648000807QuickTalker FT 12Ablenet, Inc.100000372023-06-21
00186648000814QuickTalker FT 23Ablenet, Inc.100000382023-06-21
00850011150078LITTLEmackAblenet, Inc.100000422023-06-21
00850011150085BIG Step-by-StepAblenet, Inc.100000432023-06-21
00850011150092LITTLE Step-by-StepAblenet, Inc.100000442023-06-21
00850011150108iTalk2Ablenet, Inc.100000452023-06-21
00850011150184BIG TalkingBrixAblenet, Inc.100000502023-06-21
00864705000303EyegazeLC TECHNOLOGIES, INC.12022-03-10