FDA.reportPublic FDA data

Lingraphica

Primary DI
00850042278147
Brand
Lingraphica
Company
Lingraphicare America, Inc.
Model
AllTalk
Device description
"Speech Generating Device - Lenovo Yoga 720 - 13.3"""
Published
2022-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00850042278147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042278147008500422781478500422781470850042278147

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
053502436
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850042278000LingraphicaTouchTalk2022-07-22
00850042278017LingraphicaMiniTalk2022-07-22
00850042278024LingraphicaAllTalk2022-07-22
00850042278031LingraphicaTouchTalk Plus2022-07-22
00850042278048LingraphicaTouchTalk Plus2022-07-22
00850042278055LingraphicaMiniTalk2022-07-22
00850042278062LingraphicaMiniTalk2022-07-22
00850042278079LingraphicaTouchTalk2022-07-22
00850042278086LingraphicaTouchTalk2022-07-22
00850042278093LingraphicaTouchTalk2022-07-22
00850042278109LingraphicaTouchTalk2022-07-22
00850042278116LingraphicaTouchTalk2022-07-22
00850042278123LingraphicaTouchTalk2022-07-22
00850042278130LingraphicaAllTalk2022-07-22
00850042278154LingraphicaAllTalk2022-07-22
00850042278161LingraphicaAllTalk2022-07-22
00850042278178LingraphicaAllTalk2022-07-22
00850042278185LingraphicaAllTalk2022-07-22
00850042278192LingraphicaAllTalk2022-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812324018315Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018322Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018339Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018346Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018353Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018360Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018377Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018384Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018391Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018407Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018414Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018421Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018438Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018445Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018452Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018469Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018476Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018483Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018490Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018506Series 7 Anacom MedTekAnacom MedtekILQ2026-09-30
00812324018513Series 8 Anacom MedTekAnacom MedtekILQ2026-09-30
00887761943131Voalte Nurse CallHILL-ROM, INC.ILQ2026-09-28
00840828197014RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-08-18
00840828196895PAD-CORDED,UNDER SEAT,10"X15",92" CORDCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-23
00840828196901PAD WIRELESS, UNDER SEAT, 10"X15"CURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-23
00840828196710P4600 90°,S4600,1 FT,R6,PS BREAKAWAYCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
008408281967274600,R6,BASIC,2 LT,DVCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
008408281967344600,R6,ENH,2 LT,DVCURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
00840828196741RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08
00840828196765RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-07-08