NuPoint

Basic Information

• Brand Name: NuPoint
• Primary DI: 00858526006606
• Version / Model: NP
• Company Name: PRENTKE ROMICH COMPANY
• Labeler DUNS: 080143399
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: cfe1c974-063e-4a03-b598-5581a9b24f14

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILQ	System, Communication, Powered	Physical Medicine	890.3710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17187	Voice synthesizer/digitizer	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858526006606	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 0 – 45 Degrees Celsius