2003P-0555 - Maintain the Electroconvulsive Therapy Device in Class III for All Indications
FDA Comment Number : EC20
Submitter : Ms. Margaret Jongeneel Date & Time: 06/10/2004 05:06:28
Organization : Patients Rights Abvocacy
Other Organization
Category :
Issue Areas/Comments
GENERAL
GENERAL
I would like to object to the action of the FDA to reclassify shock machines as "safe" Seeing they have never been tested at all by any reliable methods how can they be classifed as safe and put into class 11? Thousands of past recipients of this dangerous and cruel treatment who have complained about it cannot be wrong. I had it forced on me as a teenager many years ago and have never forgotten the devastating effects. How can I?.The damage is still apparent in me today.Please keep these machines where they should be as dangerous appliances,or better still as instruments of torture in class 111.