I am not sure whether or not it is FDA approved. However, insurance does pay for certain condition. Unfortunately, it is not paid by insurance. You will need a prescription from your doctor. Perhaps you can start with your pain doctor. I had a total of 50 sessions. The first 30X really helped me a lot. I got a discount from the provider. Give it a try. I think the sooner the better. The subsequent 20x which i had a year later did not seem to have the same effects as the first 30X. They still helped but not as much as the first time.