NuPoint

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…

Registry build 21.09.26

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.

1manufacturer
1catalogue number
4510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code ILQ
Manufacturer City Province Registered as Device types
Shenzhen Contin Medical Device Co., Ltd. Shenzhen Guangdong Contract manufacturer 3

Record

Regulatory record for NuPoint
Listed by Prentke Romich Co., United States
FDA product code ILQ
Device type System, Communication, Powered
Device class Class 2
Regulation 21 CFR 890.3710
Establishment Manufacturer
Premarket notification Exempt
Record published 2016-09-24
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Over the counter Yes
Label carries serial number
Storage Handling environment humidity up to 95 % RH; Storage environment temperature -20 to 50 °C; Handling environment temperature 0 to 45 °C

Catalogue Numbers

Catalogue numbers for NuPoint
Catalogue number Size Status
NP In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
GEN4 Direct Access Curbell Medical Products, Inc. 1,343
GEN4 Interactive Curbell Medical Products, Inc. 1,005
GEN4 Plus, Direct Access Curbell Medical Products, Inc. 599
Responder 5, Interactive Curbell Medical Products, Inc. 573
Series 8 Anacom MedTek Anacom Medtek 519
Series 7 Anacom MedTek Anacom Medtek 312
GEN4 Plus, Responder 5, Enhanced Curbell Medical Products, Inc. 112
Responder 5, Enhanced Curbell Medical Products, Inc. 108
Tobii Dynavox Tobii Dynavox LLC 44
Nova Chat Prentke Romich Co. 44
GEN4 Plus, Responder 5, Standard Curbell Medical Products, Inc. 33
Saltillo Prentke Romich Co. 27

Showing 12 of 1,439. All products under System, Communication, Powered

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K925387 1993-03-29
K925527 1993-03-22
K914259 1992-02-27
K902206 1990-05-29

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer