Tobii Dynavox LLC
Coraopolis, PA, US
Tobii Dynavox LLC appears in FDA device records in Coraopolis, PA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Tobii Dynavox LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Dynavox Systems Llcenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004959902 | 3004959902 | Tobii Dynavox LLC | 1400 Cherrington Parkway, Coraopolis, PA 15108 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2960-2026 | TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799 | 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 device enclosure. | Class II | Open, Classified | |
| Z-2959-2026 | TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798 | 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 device enclosure. | Class II | Open, Classified | |
| Z-1399-2023 | Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567 | Problem maintaining the stable placement of the battery may come loose from the housing and become damaged. | Class II | Open, Classified | |
| Z-1305-2018 | Dynavox T15 Speech Generating Device ( including Batteries) | 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 be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells. This battery may cause the device case to separate a small amount. | Class II | Terminated | |
| Z-1304-2018 | Dynavox T10 Speech Generating Device ( including Batteries) | 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 be described as swelled or puffed, as gas is trapped inside the pack surrounding the cells. This battery may cause the device case to separate a small amount. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain