Accent 800

Accent™ 800 is an integrated speech device and offers advanced functionality and user-friendly features. It is the smallest and most portable PRC device that offers a variety of vocabulary…

Registry build 21.09.26

Accent™ 800 is an integrated speech device and offers advanced functionality and user-friendly features. It is the smallest and most portable PRC device that offers a variety of vocabulary options. The Accent 800 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 800 is powered by PRC’s NuVoice™ software and offers built in support resources for clinicians and clients.

1manufacturer
4catalogue numbers in this listing
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 Accent 800
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
Supplied as a kit Yes
Label carries serial number
Storage Handling environment temperature 0 to 45 °C; Storage environment temperature -20 to 50 °C; Handling environment humidity up to 95 % RH
Sizes Weight 2.4 to 2.45 lb

Catalogue Numbers

Catalogue numbers for Accent 800
Catalogue number Size Status
ACN800-20 Weight 2.4 lb In distribution
ACN800-30 Weight 2.45 lb In distribution
17348-KIT In distribution
ACN800-40 Weight 2.45 lb 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