Identity
- Trade Name
- Accent 1400 FDA UDI
- Generic Name
- Voice synthesizer/digitizer FDA UDI
- Device Name
- Accent™ 1400 is a dedicated speech-generating device (SGD) that offers user-friendly features to make communicating fast and easy for individuals with speech impairments. The large 14” screen is the perfect choice for individuals with complex access needs or those who want larger icons. The Accent 1400 offers a choice of vocabulary options featuring Unity® with LAMP/Words for Life™, CoreScanner™, and WordCore. Other available vocabulary options include Essence™ for literate adults and WordPower™. The Accent 1400 is powered by PRC’s NuVoice™ software and offers built in support resources for clinicians and clients. The Accent 1400 also offers multiple access options and accommodates the NuEye™ Tracking System and the NuPoint Head-tracking System. FDA UDI
- Model / Reference
- ACN1400 FDA UDI
- Description
- Accent™ 1400 is a dedicated speech-generating device (SGD) that offers user-friendly features to make communicating fast and easy for individuals with speech impairments. The large 14” screen is the perfect choice for individuals with complex access needs or those who want larger icons. The Accent 1400 offers a choice of vocabulary options featuring Unity® with LAMP/Words for Life™, CoreScanner™, and WordCore. Other available vocabulary options include Essence™ for literate adults and WordPower™. The Accent 1400 is powered by PRC’s NuVoice™ software and offers built in support resources for clinicians and clients. The Accent 1400 also offers multiple access options and accommodates the NuEye™ Tracking System and the NuPoint Head-tracking System. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858526006002 FDA UDI
- FDA Product Code
- ILQ FDA UDI
- GMDN Term
- Voice synthesizer/digitizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3710 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 5.9 Pound FDA UDI
Category: Voice synthesizer/digitizer
Accent 1400 by Prentke Romich Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Prentke Romich Company
Sources (1)
- FDA UDI caf5744a-af23-4341-8f00-76b7f8a80364 36 fields · synced May 30, 2026