Who else makes this device?

Name: TouchChat Express
Brand: TouchChat Express

Physical Medicine › ProstheticSystem, Communication, Powered

TouchChat Express

TouchChat Express is a speech generating device with a 9.7 inch screen. Introducing TouchChat Express, a new communication device from Saltillo. TouchChat Express combines the popular…

Registry build 21.09.26

TouchChat Express is a speech generating device with a 9.7 inch screen. Introducing TouchChat Express, a new communication device from Saltillo. TouchChat Express combines the popular TouchChat app with the iPad or iPad mini and the ChatWrap case. Add to that industry leading service, support and training and you have the complete package.

1manufacturer

2catalogue 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 TouchChat Express
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	2017-03-15
Record revised	2019-02-13 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Over the counter	Yes
Label carries	serial number
Sizes	Weight 1.9 lb

Catalogue Numbers

Catalogue numbers for TouchChat Express
Catalogue number	Size	Status
TCE10.2		In distribution
TCE10.1	Weight 1.9 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.