FDA.reportPublic FDA data

Accent-1000

Primary DI
00816486021732
Brand
Accent-1000
Company
PRENTKE ROMICH COMPANY
Model
17345-KIT
Device description
Accent 1000 KG Bundle Kit
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

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
00816486021732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816486021732008164860217328164860217320816486021732

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.

Contacts#

Phone, Email table
PhoneEmail
800-262-1984service@prc-saltillo.com

Regulatory Flags#

DUNS number
080143399
Device count
1
Premarket exempt
true
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816486021695Via Pro 25 Loc TG19233-25-A2026-04-23
00816486021701Via Pro 42 Loc TG19233-42-A2026-04-23
00816486021718Via Pro 60 Loc TG19233-60-A2026-04-23
00816486021725Accent-80017348-KIT2026-04-22
00816486021749Accent-140017342-KIT2026-04-22
00816486021640PRC-SaltilloPredictable App2026-03-10
00816486021572LAMP WFL Discover AppLAMP WFL Discover204262025-10-13
00816486021626Unity AAC AppUnity AAC204252025-10-13
00816486021633Unity Discover AppUnity2025-08-05
00816486021541PRC-SaltilloVia Nano 6.120170-102025-02-06
00816486021015SaltilloTouchChat App186262023-11-08
00816486021022SaltilloTouchChat App18626-02023-11-08
00816486021039SaltilloTouchChat App18626-12023-11-08
00816486021053SaltilloTouchChat App18626-42023-11-08
00816486021060PRCQuasselkiste App19285-22023-11-08
00816486021077PRCLAMP WFL (UK) App16659-22023-11-08
00816486021084PRCLAMP WFL App166592023-11-08
00816486021183PRC-SaltilloDialogue App183122023-11-08
00816486021237EloquenceEloquence App196832023-11-08
00816486021367PRC-SaltilloDiscover App19285-92023-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G783OSKOL20IrisbondIRISBOND CROWDBONDING SL.ILQ2025-08-01
00812324010319Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010326Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010333Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010340Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010357Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010364Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010371Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010388Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010395Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010401Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010418Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010425Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010432Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010449Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010456Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010463Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010470Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010487Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010494Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010500Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010517Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010524Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010531Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010548Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010555Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010562Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010579Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010586Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13
00812324010593Series 8 Anacom MedTekAnacom MedtekILQ2023-07-13