Identity
- Trade Name
- NuPoint FDA UDI
- Generic Name
- Voice synthesizer/digitizer FDA UDI
- Device Name
- NuPoint is an effective access solution for users who have limited or no use of their hands. Using optical sensors, NuPoint tracks a small reflective dot on the user’s forehead, glasses or other convenient spot converting the natural movement of the user’s head to accurately control the pointer on the screen. Key activations are made by dwelling over the desired key. Additional movement settings, like vertical and horizontal controls help customize control of the pointer to optimize the user’s accuracy and ease of use. NuPoint is designed specifically to work with the Accent 1400, Accent 1000* and Accent 800**. NuPoint plugs directly into the device requiring no additional power or cables. FDA UDI
- Model / Reference
- NP FDA UDI
- Description
- NuPoint is an effective access solution for users who have limited or no use of their hands. Using optical sensors, NuPoint tracks a small reflective dot on the user’s forehead, glasses or other convenient spot converting the natural movement of the user’s head to accurately control the pointer on the screen. Key activations are made by dwelling over the desired key. Additional movement settings, like vertical and horizontal controls help customize control of the pointer to optimize the user’s accuracy and ease of use. NuPoint is designed specifically to work with the Accent 1400, Accent 1000* and Accent 800**. NuPoint plugs directly into the device requiring no additional power or cables. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858526006606 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
Category: Voice synthesizer/digitizer
NuPoint 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 cfe1c974-063e-4a03-b598-5581a9b24f14 35 fields · synced May 31, 2026