Quote:
Originally Posted by My Daily Run
Has anyone been to Dr. James Scott on 441 a Chiropractor who uses the Activator V which is the world’s first FDA registered cordless electronic chiropractic adjusting instrument. I have an appointment tomorrow. A friend of mine goes to a chiropractor that uses this method in Ca. and swears by it.
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I continue to be amazed at the misuse of the FDA's name in implying that a device is somehow either safe, effective, or has passed any kind of FDA approval for treatment of disease. This device is a battery powered plunger
"The Activator V is a hand-held electromechanical chiropractic adjusting instrument with a plunger-like mechanism that is intended to be used for chiropractic adjustment of the spine and extremities. The device is only intended to be used by a health care professional licensed by the state in which he or she practices. The thrust is provided by battery power rather than manual force. This makes it easier and less tiring for the chiropractor."
The FDA simply said that because this device is essentially the same as devices which were already marketed prior to the FDA being given regulatory authority over devices, they had no authority to assess the Activator V. And they did not. So the term "registered" is accurate but clearly misleads people into believing that the FDA has passed a positive judgment on it.
the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act.
Having said that, I know nothing about the specific chiropractor.