Nova Chat
Nova Chat 12.1 is a speech generating device with a 12 inch screen. The Nova chat 12 has a 12.2 inch LCD display- the largest in the Chat line of products. It is a speech-generating device…
Nova Chat 12.1 is a speech generating device with a 12 inch screen. The Nova chat 12 has a 12.2 inch LCD display- the largest in the Chat line of products. It is a speech-generating device that offers the well-known Chat Software on an Android platform. Like all “Chats,” NOVA chat 12 offers a durable yet sleek, portable design, with features that include a built-in camera, single or dual switch scanning, Social Chat, IVONA speech synthesizer, and many other exciting features
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 | 2017-05-15 |
| Record revised | 2019-02-13 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Sizes | Weight 0.55 to 2.85 lb |
| Distribution end date | 2019-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NC8.3-60-KG | In distribution | |
| NC10.4-20-KG | In distribution | |
| NC12.1-80-KG | In distribution | |
| NC10.5-15-KG | In distribution | |
| NC8.2-KIT-KG | In distribution | |
| NC12.1-KIT-KG | In distribution | |
| NC12.1 | Weight 2.85 lb | In distribution |
| NC8.2-42-KG | In distribution | |
| NC10.5-KIT-KG | In distribution | |
| NC10.5-48-KG | In distribution | |
| NC8.2-15-KG | In distribution | |
| NC10.4-42-KG | In distribution | |
| NC5.3 | Weight.55 lb | In distribution |
| NC8.3-KIT-KG | In distribution | |
| NC10.4-KIT-KG | In distribution | |
| NC8.2-20-KG | In distribution | |
| NC10.5-108-KG | In distribution | |
| NC8.2-48-KG | In distribution | |
| NC8.3-42-KG | In distribution | |
| NC10.4-15-KG | In distribution | |
| NC12.1-20-KG | In distribution | |
| NC8.2-80-KG | In distribution | |
| NC12.1-60-KG | In distribution | |
| NC8.3-20-KG | In distribution | |
| NC10.5-80-KG | In distribution | |
| NC8.3-15-KG | In distribution | |
| NC10.4-60-KG | In distribution | |
| NC8.3-25-KG | In distribution | |
| NC10.5-42-KG | In distribution | |
| NC12.1-42-KG | In distribution | |
| NC8.3-80-KG | In distribution | |
| NC8.2-60-KG | In distribution | |
| NC12.1-108-KG | In distribution | |
| NC8.2-108-KG | In distribution | |
| NC10.5-20-KG | In distribution | |
| NC10.4-80-KG | In distribution | |
| NC12.1-48-KG | In distribution | |
| NC10.5-60-KG | In distribution | |
| NC10.5 | Weight 1.95 lb | In distribution |
| NC8.3-48-KG | In distribution | |
| NC12.1-15-KG | In distribution | |
| NC10.4 | Weight 1.95 lb | Withdrawn |
| NC8.3 | Withdrawn | |
| NC8.2 | Weight 1.35 lb | Withdrawn |
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 |
| GEN4 Plus, Responder 5, Standard | Curbell Medical Products, Inc. | 33 |
| Saltillo | Prentke Romich Co. | 27 |
| 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.