SEARCH   ECU WebsitePeople GO
 
College of Allied Health Sciences
Department of Communication Sciences and Disorders

Printer Friendly

undefined


 

 

 

 

 

Contact Us

For more information about the SpeechEasy Device:

Telephone:
252-744-6104

E-mail: stuttering@ecu.edu  

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

speecheasylogolarge2

 

 

 

 

 

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

speecheasylogolarge2



undefined

Contact Us
Janus Development Group, Inc.
Research Team/Background Information
Research Data
FDA Requirements
Video* - "Effect of Altered Auditory Feedback on Fluency of People Who Stutter"

(* Notice: This video is the property of East Carolina University. No part of this video shall be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, copying, recording, or otherwise.)

 


 
ecu logo
College of Allied Health Sciences | Department of Communication Sciences and Disorders
Health Sciences Building | Greenville, NC 27858-4353 USA
252.744.6100 | Contact Us
terms of use | Last Updated: 12.11.2007