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Nova Chat 10.6 is a speech generating device with a 10 inch screen. NOVA chat 10 offers the well-known Chat Software on an Android platform. Like all "Chats," NOVA chat 10 offers a durable…
Nova Chat 10.6 is a speech generating device with a 10 inch screen. NOVA chat 10 offers the well-known Chat Software on an Android platform. Like all “Chats,” NOVA chat 10 offers a durable yet sleek portable design, with features that include a 10″ display, switch scanning, Social Chat, IVONA speech synthesizer, and many other Chat features. Now also available in an Active case.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Contin Medical Device Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 3 |
Record
| 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 | 2020-10-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NC8.4 | In distribution | |
| VC7.1 | In distribution | |
| NC10.6-25-KG | In distribution | |
| NC10.6-32-KG | In distribution | |
| TouchChat App | In distribution | |
| NC10.6-108-KG | In distribution | |
| 19254-20 | In distribution | |
| NC10.6-15-KG | In distribution | |
| NC5.4 | In distribution | |
| TouchChat App | In distribution | |
| 19254-60 | In distribution | |
| NC10.6-80-KG | In distribution | |
| 19254-48 | In distribution | |
| NC8.35 | In distribution | |
| 19254-25 | In distribution | |
| TouchChat App | In distribution | |
| 19254-15 | In distribution | |
| NC10.6-60-KG | In distribution | |
| 19254-42 | In distribution | |
| NC10.6 | In distribution | |
| 19254-24I | In distribution | |
| 19254 | In distribution | |
| NC10.6-48-KG | In distribution | |
| 19254-60I | In distribution | |
| NC10.6-60I-KG | In distribution | |
| NC10.6-KIT-KG | In distribution | |
| NC10.6-42-KG | In distribution |
Same 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 |
| NovaChat | Prentke Romich Co. | 22 |
Showing 12 of 1,439. All products under System, Communication, Powered
510(K) Clearances
| 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.