Pain Management Q&A by Dr. Helm
The FDA is concerned about the safety of devices. In this instance, the device has a 510k "approval," which means that it is "substantially equivalent" to another device which had previously been shown to be safe. Medical devices must have some form of FDA approval prior to being marketed. Since this device is approved, it is legal to market it. This approval says nothing about the effectiveness of the device. Effectiveness is a separate issue not addressed by the FDA. It is up to the purchaser to determine whether the information provided is sufficient to document effectiveness.
Thank you for your question.
Last Editorial Review: 1/2/2007