Accent 1000 Tactile Keyguide 84 Location (Lamp WFL VI)

This Keyguide is made from clear polycarbonate material and precisely engineered to help guide the user’s touch to targeted icons on the screen and reduce accidental activations. A tactile…

Registry build 21.09.26

This Keyguide is made from clear polycarbonate material and precisely engineered to help guide the user’s touch to targeted icons on the screen and reduce accidental activations. A tactile Keyguide allows the Accent 1000 to be set up to accommodate a wide range of cognitive and motor skills for the visually impaired. Using the Keyguide with the 1000 requires the device frame that came with the 1000. This keyguide has rectangular/oval openings and tactile ques for the visually impaired.

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 Accent 1000 Tactile Keyguide 84 Location (Lamp WFL VI)
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 2018-11-29

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Over the counter Yes

Catalogue Numbers

Catalogue numbers for Accent 1000 Tactile Keyguide 84 Location (Lamp WFL VI)
Catalogue number Size Status
18711-84 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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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