FDA-Device2023-04-26Class II

Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567

Tobii Dynavox Llc
Hazard

Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.

Sold states
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, Croatia, Denmark, Estonia, Finland, France, Germany, Iceland Ireland, Italy, Latvia, Netherlands, Norway, Saudi Arabia, Slovakia, Slovenia, Sweden, United Arab Emirates, United Kingdom.
Affected count
3924 units
Manufactured in
2100 Wharton St Ste Ste 400, N/A, Pittsburgh, PA, United States
Products
Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1399-2023

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