Action is needed now, survivors! The FDA is pushing to downgrade shock machines to class II devices that puts it on equal level risk to a wheelchair.
An FYI to those who don’t know, shock machines have never been tested by the FDA. Shock survivor or no, you should be outraged at the government entity charged with protecting American citizens from harmful drugs and devices is so eager to reduce protection for a device that has been shown to cause death by complications or suicide and brain damage and permanent disability, that has never been officially tested. This is inexcusable.
“Are you over 18? Treatment Resistant? Require Rapid Response? Watch out! The FDA as a proposed rule under public inspection, just for you! During this public inspection period, tell the FDA NO to the down-classification of shock devices. Tell the FDA exactly how subjective “treatment resistant” and “require rapid response” are as concepts.”