FDA.reportPublic FDA data

Talk Pad

Primary DI
00850041729121
Brand
Talk Pad
Company
Talk To ME Technologies, LLC
Model
8
Device description
Talk Pad 8: Wego Edition Speech Generating Device
Published
2023-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850041729121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041729121008500417291218500417291210850041729121

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

Regulatory Flags#

DUNS number
002607830
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850041729145zuvo12 with Vida Go2024-02-05
00850041729152Zuvo16 with Vida Go2024-02-05
00850041729046zuvo102022-08-25
00850041729053zuvo122022-08-24
00850041729060zuvo162022-08-24
00850041729077zuvo12 with eyespeak2022-08-24
00850041729084zuvo16 with eyespeak2022-08-24
00850041729091zuvo12 with eyespeak inspo2022-08-24
00850041729107zuvo16 with eyespeak inspo2022-08-24
00850041729237Grid Pad 13 with EvoEVO-KIT132025-10-24
00850041729244Grid Pad 16 with EvoEVO-KIT162025-10-24
00850041729206Grid Pad 16GP16A2025-04-02
00850041729213Grid Pad 16 Lumin-iLUMIN-I-KIT162025-04-02
00850041729220Grid Pad 16 VidaVIDA-KIT162025-04-02
00850041729190Grid Pad Go102024-12-02
00850041729176Grid Pad 13 Lumin-iLUMIN-I-KIT132024-03-15
00850041729183Grid Pad 13GP13A2024-03-15
00850041729169Grid Pad 13 VidaVIDA-KIT132024-03-14
00850041729138Talk Pad102023-09-08
00850041729022wego10A2022-08-24

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Primary DI, Brand, Company table
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00816486021671Genesis™ 13 CHG EXTPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021688Genesis™ 16 CHG EXTPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021763Genesis™ 13 144 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021770Genesis™ 13 45 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021787Genesis™ 13 60 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
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00816486021824Genesis™ 13 36 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021831Genesis™ 13 8 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
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00816486021855Genesis™ 13 28 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021862Genesis™ 13 36 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
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00816486021893Genesis™ 13 8 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021909Genesis™ 13 84 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021916Genesis™ 13 144 Location TouchGuidePRENTKE ROMICH COMPANYILQ2026-10-21
00816486021923Genesis™ 16 144 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021930Genesis™ 16 45 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021947Genesis™ 16 60 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021954Genesis™ 16 84 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021961Genesis™ 16 15 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021978Genesis™ 16 28 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021985Genesis™ 16 36 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21
00816486021992Genesis™ 16 8 Location KeyGuardPRENTKE ROMICH COMPANYILQ2026-10-21