GEN4 Plus, Responder 5, Enhanced
112 catalogue numbers from 5C410U-50103001A, listed by Curbell Medical Products, Inc., United States, under System, Communication, Powered. 1 manufacturer in China is registered for this product code.
1manufacturer
112catalogue numbers in this listing
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 | Curbell Medical Products, Inc., United States |
|---|---|
| FDA product code | ILQ |
| Device type | System, Communication, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3710 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-04-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5C410U-50103001A | In distribution | |
| 5C410U-00148000A | In distribution | |
| 5C410U-10003001A | In distribution | |
| 5C410U-10144001A | In distribution | |
| 5C410U-10103005A | In distribution | |
| 5C410U-00100000F | In distribution | |
| 5C410U-10054001A | In distribution | |
| 5C410U-10103001A | In distribution | |
| 5C410U-16503021A | In distribution | |
| 5C410U-10103063F | In distribution | |
| 5C415U-00145000A | In distribution | |
| 5C415U-00117000A | In distribution | |
| 5C410U-17303001A | In distribution | |
| 5C410U-80063001A | In distribution | |
| 5C410U-16503023A | In distribution | |
| 5C415U-26347001A | In distribution | |
| 5C410U-101560031 | In distribution | |
| 5C410U-10110001A | In distribution | |
| 5C410U-16503001A | In distribution | |
| 5C412U-001022A | In distribution | |
| 5C410U-10134003A | In distribution | |
| 5C410U-50104001A | In distribution | |
| 5C410U-00104002A | In distribution | |
| 5C410U-16560001A | In distribution | |
| 5C410U-10117001A | In distribution | |
| 5C410U-10104003A | In distribution | |
| 5C410U-15503001A | In distribution | |
| 5C415U-20103001A | In distribution | |
| 5C410U-10103031A | In distribution | |
| 5C410U-00104000A | In distribution | |
| 5C410U-10104003F | In distribution | |
| 5C410U-10156003A | In distribution | |
| 4C410U-101231A | In distribution | |
| 5C410U-16503003A | In distribution | |
| 5C410U-10148001A | In distribution | |
| 5C410U-00100000A | In distribution | |
| 5C410U-10103009A | In distribution | |
| 5C410U-16504003A | In distribution | |
| 5C410U-101030010 | In distribution | |
| 4C410U-1010014 | In distribution | |
| 5C410U-10137003A | In distribution | |
| 5C410U-00100002A | In distribution | |
| 5C410U-101030031 | In distribution | |
| 5C410U-06600000A | In distribution | |
| 5C410U-10000001A | In distribution | |
| 5C410U-10146001A | In distribution | |
| 5C410U-10140001A | In distribution | |
| 5C410U-16103003A | In distribution | |
| 5C410U-D7003003A | In distribution | |
| 5C410U-10161001A | In distribution | |
| 5C410U-10057001A | In distribution | |
| 5C410U-10103003A | In distribution | |
| 5C412U-0010201 | In distribution | |
| 5C410U-10003003A | In distribution | |
| 5C412U-001370A | In distribution | |
| 5C410U-00103000F | In distribution | |
| 5C410U-16903001A | In distribution | |
| 5C415U-20100001A | In distribution | |
| 5C410U-101040011 | In distribution | |
| 5C410U-96549001A | In distribution | |
| 5C410U-16703001A | In distribution | |
| 5C410U-11403001A | In distribution | |
| 5C410U-16517003A | In distribution | |
| 5C410U-00104000F | In distribution | |
| 5C410U-10129003A | In distribution | |
| 5C410U-10103061F | In distribution | |
| 5C410U-16500001A | In distribution | |
| 5C410U-10004001A | In distribution | |
| 5C410U-10103001F | In distribution | |
| 5C410U-10000003A | In distribution | |
| 5C410U-00103002A | In distribution | |
| 5C412U-001020A | In distribution | |
| 5C410U-10103003F | In distribution | |
| 5C410U-16303001A | In distribution | |
| 5C410U-10104001A | In distribution | |
| 5C412U-0013700 | In distribution | |
| 5C410U-10134001A | In distribution | |
| 5C410U-F7103003A | In distribution | |
| 5C410U-00103000A | In distribution | |
| 5C410U-10116001A | In distribution | |
| 5C410U-10110003A | In distribution | |
| 5C410U-10154001A | In distribution | |
| 5C410U-16504003A | In distribution | |
| 5C412U-001020F | In distribution | |
| 5C410U-10156001A | In distribution | |
| 5C410U-16503003F | In distribution | |
| 5C410U-17203001A | In distribution | |
| 5C410U-10134041A | In distribution | |
| 5C410U-17503001A | In distribution | |
| 5C410U-B6503003A | In distribution | |
| 5C410U-10103007A | In distribution | |
| 5C410U-86500021A | In distribution | |
| 5C410U-10100003A | In distribution | |
| 5C410U-H0104001A | In distribution | |
| 5C410U-169030010 | In distribution | |
| 5C415U-00146000A | In distribution | |
| 5C410U-10129001A | In distribution | |
| 5C410U-101030011 | In distribution | |
| 5C410U-06239000A | In distribution | |
| 5C410U-86549001A | In distribution | |
| 5C410U-10100001A | In distribution | |
| 5C410U-10158003A | In distribution | |
| 5C413N-10100001A | In distribution | |
| 5C410U-B6503003F | In distribution | |
| 5C410U-17203003A | In distribution | |
| 5C410U-50104003A | In distribution | |
| 5C410U-10153001A | In distribution | |
| 5C410U-10156001A | In distribution | |
| 5C410U-16103001A | In distribution | |
| 5C410U-86503021A | In distribution | |
| 5C410U-10159003A | In distribution | |
| 5C410U-10148001F | 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 |
| 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 |
| NovaChat | Prentke Romich Co. | 22 |
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.