Identity
- Trade Name
- NuEye™ FDA UDI
- Generic Name
- Voice synthesizer/digitizer FDA UDI
- Device Name
- The NuEye™ Tracking System is setting a new standard for eye gaze systems. Compatible with the Accent 1400, Accent 1200* and Accent 1000, now you can access the full communication & computing power with just your eyes! Note: Photos show NuEye™ Tracking System module only and attached to an Accent 1400. The NuEye Tracking System attaches quickly to the Accent 1400, Accent 1200 or Accent 1000 device to give users full visual control of the device. Keys are "selected" by gazing for a specified period of time to generate speech. Developed in partnership with SensoMotoric Instruments GmbH (SMI) of Germany, a global leader in eye tracking technology for more than 20 years. NuEye is ideal for children and adults who need hands-free and switch-free device access. FDA UDI
- Model / Reference
- NE FDA UDI
- Description
- The NuEye™ Tracking System is setting a new standard for eye gaze systems. Compatible with the Accent 1400, Accent 1200* and Accent 1000, now you can access the full communication & computing power with just your eyes! Note: Photos show NuEye™ Tracking System module only and attached to an Accent 1400. The NuEye Tracking System attaches quickly to the Accent 1400, Accent 1200 or Accent 1000 device to give users full visual control of the device. Keys are "selected" by gazing for a specified period of time to generate speech. Developed in partnership with SensoMotoric Instruments GmbH (SMI) of Germany, a global leader in eye tracking technology for more than 20 years. NuEye is ideal for children and adults who need hands-free and switch-free device access. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858526006590 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 — 0.29 Pound FDA UDI
Category: Voice synthesizer/digitizer
NuEye™ by Prentke Romich Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Voice synthesizer/digitizer.
- Lingraphica — LINGRAPHICARE AMERICA, INC. · Class II
- G13 — SMARTBOX ASSISTIVE TECHNOLOGY INC · Class II
- Lingraphica — LINGRAPHICARE AMERICA, INC. · Class II
- NeuroSwitch — CONTROL BIONICS INCORPORATED · Class II
- Talk Pad — Talk To ME Technologies, LLC · Class II
- L10 — SMARTBOX ASSISTIVE TECHNOLOGY INC · Class II
- WinSlate — FORBES REHAB SERVICES INC. · Class II
- G16 — SMARTBOX ASSISTIVE TECHNOLOGY INC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prentke Romich Company
Sources (1)
- FDA UDI ddb1e001-0dfb-4d37-bd53-e06371d70e2f 36 fields · synced Jun 8, 2026