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[Dysphagia] Use of e-stim for speech and swallowing disorders
- Subject: [Dysphagia] Use of e-stim for speech and swallowing disorders
- From: kevdlambert at comcast.net (Kevin Lambert)
- Date: Wed Mar 1 19:05:51 2006
- References: <2eb.1ff94e7.3137687b@aol.com>
The enclosure included with the letter to the FDA says:
Indications for Use: Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contractions. It is signed off by Mark N. Milkerson from the FDA Division of General, Restorative and Neurological Devices. Look at the last page labeled: "Concurrence of CDRH, Office of Device Evaluation (ODE)"
http://www.vitalstim.com/pdf/FDA%20510k%20clearance%20letter.pdf
----- Original Message -----
From: Drirenect@aol.com
To: kevdlambert@comcast.net ; Dysphagia@b9.com
Sent: Wednesday, March 01, 2006 4:13 PM
Subject: Re: [Dysphagia] Use of e-stim for speech and swallowing disorders
If you check the FDA letter you find that it is NOT approved for dysphagia - it is approved because it is no different from other devices already on the market. The letter is available on the FDA website.
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