Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005301283

FEI Number

3005301283

Entity Name

DYNAVOX Group AB

City/State/Country

Stockholm, SE

Establishment Address

Lojtnantsgatan 25, Stockholm SE11550, SE

Establishment Type(s)

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

Owner / Operator

Tobii Dynavox LLC (Owner Number: 9076359)

Owner / Operator Contact Address

2100 Wharton Street, Suite 400, Pittsburgh, PA 15203, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

I-16 TD I-110 TD Pilot I-110 I-15+ I-12+ I-13 TD I-13 TD I-16

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	2005-08-12

Official Correspondent

Tony Pavlik

US Agent Details

Tony Pavlik Business: Tobii Dynavox LLC Email: tony.pavlik@tobiidynavox.com Phone: (412) 3814883

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
3004959902	Tobii Dynavox LLC	Coraopolis, PA, US

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005301283. Last updated year: 2026. Please use registration number 3005301283 when referencing this establishment in official correspondence.