NovaChat
Nova Chat 10.7 is a speech generating device with a 10 inch screen.
1manufacturer
22catalogue numbers in this listing
4510(k) clearances naming this product code
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 | 2023-06-20 |
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 |
| Storage | Handling environment temperature 5 to 40 °C; Storage environment temperature -25 to 70 °C; Handling environment humidity 15 to 93 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
| Sizes | Length 7.46 to 9.6 in; width 4.42 to 7.3 in; height 0.16 to 2 in; weight 2.1 lb |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NC8.5 | Weight 2.1 lb | In distribution |
| 19584 | In distribution | |
| 20062-15 | Length 7.94 in | In distribution |
| 19584-42 | In distribution | |
| NC10.7 | In distribution | |
| 20066-42 | Length 7.46 in | In distribution |
| 19528-20 | In distribution | |
| 19584-60 | In distribution | |
| 19584-25 | In distribution | |
| 19528 | In distribution | |
| 19528-60 | In distribution | |
| 19528-15 | In distribution | |
| 20062-42 | Length 7.94 in | In distribution |
| 20062-20 | Length 7.94 in | In distribution |
| 19528-25 | In distribution | |
| 19528-84 | In distribution | |
| 19528-42 | In distribution | |
| 20062-60 | Length 7.94 in | In distribution |
| 20066-25 | Length 7.46 in | In distribution |
| 20062-84 | Length 7.94 in | In distribution |
| 20066-60 | Length 7.46 in | In distribution |
| 20062-25 | Length 7.94 in | 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 |
| Saltillo | Prentke Romich Co. | 27 |
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.