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Tobii Dynavox

FDA UDI

Class II (US FDA UDI)

by Tobii Dynavox LLC

Identity

Trade Name
Tobii Dynavox FDA UDI
Generic Name
Voice synthesizer/digitizer FDA UDI
Device Name
A Speech Generating Device with Eyegaze access. A deployed Surface Pro Windows use by people with severe speech impairment and physical limitations. The deployment included speech software from Tobii Dynavox including Snap+Core First. FDA UDI
Model / Reference
EM-12 FDA UDI
Description
A Speech Generating Device with Eyegaze access. A deployed Surface Pro Windows use by people with severe speech impairment and physical limitations. The deployment included speech software from Tobii Dynavox including Snap+Core First. FDA UDI

Identifiers

Catalog Number
750547 FDA UDI
Primary DI / UDI-DI
07340074601141 FDA UDI
FDA Product Code
ILQ FDA UDI
GMDN Term
Voice synthesizer/digitizer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.3710 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Voice synthesizer/digitizer

Tobii Dynavox by Tobii Dynavox LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Voice synthesizer/digitizer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tobii Dynavox LLC

Sources (1)

  • FDA UDI 97628290-45f0-453b-a3b6-a1b0bcfd9e68 35 fields · synced Jun 8, 2026