Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004959902

FEI Number

3004959902

Entity Name

Tobii Dynavox LLC

City/State/Country

Coraopolis, PA, US

Establishment Address

1400 Cherrington Parkway, Building 100, Coraopolis, PA 15108, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Tobii Dynavox LLC (Owner Number: 10039853)

Owner / Operator Contact Address

1400 Cherrington Parkway, Coraopolis, PA 15108, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SC Tablet Mini TD Navio Maxi I-110 Indi 7 TD Navio Midi TD I-13 TD I-16 SC Tablet I-13 TD Navio Mini I-16 TD Pilot TD I-110

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILQ	System, Communication, Powered	Physical Medicine	Class 2	890.3710	2014-05-01

Official Correspondent

Tony Pavlik

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tobii Dynavox LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005301283	DYNAVOX Group AB	Stockholm, SE

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2016	Lifeline Systems, Incorporated	2	Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.

Similar Registrations

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3008994998	EYETECH DIGITAL SYSTEMS	Tempe, AZ, US
3005301283	DYNAVOX Group AB	Stockholm, SE
3007275470	JABBLA	Gent Oost-Vlaanderen, BE
3007883990	SMARTBOX US	Cedar Falls, IA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004959902. Last updated year: 2026. Please use registration number 3004959902 when referencing this establishment in official correspondence.