5  Compliance Information

5.1  Australia

The Test of Variables of Attention (T.O.V.A.) is a Class I medical device registered with the Australian Government’s Therapeutic Goods Administration (TGA) under Australian Register of Therapeutic Goods (ARTG) Identifier 315322.

5.2  Australian Sponsor

Emergo Australia
Level 20, Tower II
Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia

5.3  Canada

The Test of Variables of Attention (T.O.V.A.) is licensed by Health Canada as a Class I medical device manufactured under Medical Device Establishment License (MDEL) Number 9655.

5.4  European Union

The Test of Variables of Attention (T.O.V.A.) is a Class I medical device manufactured in accordance with the European Union’s Medical Device Directive (MDD 93/42/EEC).

5.5  European Authorized Representative Information

For vigilance inquiries, use EmergoVigilance@ul.com

5.6  United States

The Test of Variables of Attention (T.O.V.A.) has been cleared for sale in the United States by the U.S. Food and Drug Administration (FDA).