For more information about the SpeechEasy Device:
For purchase information and to locate a SpeechEasy Dispenser near you, please go to the Janus Development Group, Inc. website.
Food & Drug Administration
The United States Food and Drug Administration has exempted most Class 1 devices. The SpeechEasy fluency device falls under the exempt group within Class 1 of the 510(k) classification of anti-stammering devices.
However, manufacturers are required to register with the FDA. On Aug. 12, 2001, the FDA issued the following device establishment registration number for the SpeechEasy.
FDA Registration Number: 1066749
Product Code: KTH
Document Listing Number: 8120987
FDA Webpage registration link