FDA.report

zuvo

Primary DI
00850041729084
Brand
zuvo
Company
Talk To ME Technologies, LLC
Model
16 with eyespeak
Device description
zuvo 16 with eyespeak, speech generating device
Published
2022-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ILQSystem, Communication, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
ILQSystem, Communication, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850041729084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041729084008500417290848500417290840850041729084

GMDN Terms

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

Regulatory Flags

DUNS number
002607830
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00850041729145zuvo12 with Vida Go2024-02-05
00850041729152Zuvo16 with Vida Go2024-02-05
00850041729121Talk Pad82023-09-08
00850041729138Talk Pad102023-09-08
00850041729046zuvo102022-08-25
00850041729022wego10A2022-08-24
00850041729039wego13A2022-08-24
00850041729053zuvo122022-08-24
00850041729060zuvo162022-08-24
00850041729077zuvo12 with eyespeak2022-08-24
00850041729091zuvo12 with eyespeak inspo2022-08-24
00850041729107zuvo16 with eyespeak inspo2022-08-24
00850041729114wegowrite2022-08-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860014667602MedMinder Systems, Inc.MEDMINDER SYSTEMS, INC.ILQ2026-03-23
00840828196123RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00840828196130RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00840828196147RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00840828196154RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-11
00816486021640PRC-SaltilloPRENTKE ROMICH COMPANYILQ2026-03-10
00840828196093RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-04
00840828196024RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-03
00840828196048RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-03-03
00840828195966ZEPHYR,800,10,PUFF,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195973ZEPHYR,800,10,SIP=N,PUFF=TV,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195980ZEPHYR,800,10,SIP=TV,PUFF=N,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195997ZEPHYR,800,10,SIP,JERON 680CURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-11
00840828195911RESPONDER 5, INTERACTIVECURBELL MEDICAL PRODUCTS, INC.ILQ2026-02-03
00812324018308Series 8 Anacom MedTekAnacom MedtekILQ2026-01-27
00812324018094Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018100Series 7 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018117Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018124Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018131Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018148Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018155Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018162Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018179Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018186Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018193Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018209Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018216Series 7 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018223Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22
00812324018230Series 8 Anacom MedTekAnacom MedtekILQ2026-01-22