← Back to catalogue

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
TD I-110 Portable Speech Generating Device designed for people who can not speak due to injury, illness or disability. Durable, lightweight unit, IP55 with Gorilla Glass. FDA UDI
Model / Reference
TD I-110 FDA UDI
Description
TD I-110 Portable Speech Generating Device designed for people who can not speak due to injury, illness or disability. Durable, lightweight unit, IP55 with Gorilla Glass. FDA UDI

Identifiers

Catalog Number
750567 FDA UDI
Primary DI / UDI-DI
07340074601714 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

No

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Tobii Dynavox LLC

Sources (1)

  • FDA UDI 862ab2b7-255a-43b9-98ec-b9478d52f27e 35 fields · synced May 29, 2026