Italk4

The easiest way to provide an individual with four side-by-side communication choices is with the iTalk4 speech device. Activate the colored top to play the desired message. New messages…

Registry build 21.09.26

The easiest way to provide an individual with four side-by-side communication choices is with the iTalk4 speech device. Activate the colored top to play the desired message. New messages are easily and quickly recorded to the iTalk4 on the fly, or use the levels pre-record up to three sets of messages ahead of time. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Provide a unique response to a question like “What is the weather like outside?” Respond to an assessment Provide a way to make unique requests like “I need help”, “I’m done”, “I need to use the bathroom”, and “I’m thirsty” Add communication to a switch controlled toy or appliance Features Better than ever digital sound output suitable for almost any environment Clear snap cover to attach picture symbols and provide communication context to the user Symbol Overlays Symbol overlays are not included with the iTalk4. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.

1manufacturer
1catalogue number

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 iTalk4
Listed by Ablenet, Inc., United States
FDA product code ILQ
Device type System, Communication, Powered
Device class Class 2
Regulation 21 CFR 890.3710
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2023-06-21

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for iTalk4
Catalogue number Size Status
10000028 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

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