East Carolina University
 
College of Allied Health Sciences
Department of Communication Sciences and Disorders


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Contact Us

For more information about the SpeechEasy Device:

Telephone:
252-744-6104

For purchase information and to locate a SpeechEasy Dispenser near you, please go to the Janus Development Group, Inc. website.

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FDA Requirements

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

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