Tobii Dynavox
TD Navio Midi, Model: TDNM1, is a Speech Generating Device (aka AAC Device), Powered Communication System. It is a midsized, lightweight, portable iOS-based device. The unit comes with its…
TD Navio Midi, Model: TDNM1, is a Speech Generating Device (aka AAC Device), Powered Communication System. It is a midsized, lightweight, portable iOS-based device. The unit comes with its communication software in order meet the needs of individuals who cannot speak.
1manufacturer
44catalogue numbers in this listing
5recalls on this 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 | Tobii Dynavox LLC, United States |
|---|---|
| FDA product code | ILQ |
| Device type | System, Communication, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3710 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-07-30 |
| Record revised | 2018-05-15 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -30 to 70 °C; Storage environment humidity 5 to 95 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| Distribution end date | 2022-03-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SC Tablet | In distribution | |
| TD Navio Midi | In distribution | |
| EM-12 | In distribution | |
| SC Tablet Mini | In distribution | |
| TD Navio Mini | In distribution | |
| TD Pilot 2 | In distribution | |
| TD I-110 | In distribution | |
| I-13 | In distribution | |
| TDGG2 | In distribution | |
| TD I-13 | In distribution | |
| NGE60-TD | In distribution | |
| TD I-16 | In distribution | |
| TD I-110 | In distribution | |
| TD Navio Maxi | In distribution | |
| TD Pilot | In distribution | |
| I-16 | In distribution | |
| SC Tablet | Withdrawn | |
| T15 | Withdrawn | |
| SC Tablet | Withdrawn | |
| T10 | Withdrawn | |
| SC Tablet | Withdrawn | |
| I-15+ IS4 | Withdrawn | |
| SC Tablet | Withdrawn | |
| SC Tablet | Withdrawn | |
| SC Tablet | Withdrawn | |
| I-12+ IS20 | Withdrawn | |
| SC Tablet | Withdrawn | |
| Indi | Withdrawn | |
| SC Tablet | Withdrawn | |
| I-15+ IS20 | Withdrawn | |
| SC Tablet | Withdrawn | |
| SC Tablet | Withdrawn | |
| SC Tablet | Withdrawn | |
| T7 | Withdrawn | |
| SC Tablet | Withdrawn | |
| Indi 7 | Withdrawn | |
| SC Tablet | Withdrawn | |
| SC Tablet | Withdrawn | |
| I-110 | Withdrawn | |
| I-12+ IS4 | Withdrawn | |
| SC Tablet | Withdrawn | |
| SC Tablet | Withdrawn | |
| SC Tablet | Withdrawn | |
| SC Tablet | 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 |
| 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
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-07-08 | Class II | Device Design | Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the | ||
| 2026-07-08 | Class II | Device Design | Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the | ||
| 2023-02-24 | Class II | Device Design | Problem maintaining the stable placement of the battery may come loose from the housing and become damaged. | 3924 units | |
| 2017-12-14 | Class II | Component design/selection | The battery is integral to the device. If the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire. The battery may out-gas which may | 307 | 2019-12-11 |
| 2017-12-14 | Class II | Component design/selection | The battery is integral to the device. If the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and the battery will expire. The battery may out-gas which may | 4615 | 2019-12-11 |
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.