Why Fisher Wallace Stimulators are not available on Amazon or eBay
If you are shopping for a Fisher Wallace Stimulator® on Amazon or eBay in the US, you may find that there are no products available to buy. This is because it is an FDA cleared Class III medical device and can only be obtained via a prescription.
What does FDA classified mean?
The Food and Drug Administration classifies medical devices into three categories – Class I, Class II and Class III. Class I has the lowest risk and the least restrictions on use, whilst Class III carry greater risk and regulatory control. The Fisher Wallace device is a Class III device, although after considering new evidence, the FDA has recently proposed to downgrade all CES devices to Class II.
Does this mean I have to go to my Doctor to get a prescription?
Yes you do need authorization. However, the Fisher Wallace website has made it easy for you to bypass this complication. You can obtain same day authorization by completing the online authorization form. Following this, you can then complete the purchase on the website and have it immediately shipped to you. Alternatively, you can download the offline form and have it signed by your Doctor or Medical Professional. There are other websites selling these devices and all will require authorization from a Medical Professional, so there is no getting around it.
Hold on, I have seen people selling these on eBay…
There is nothing stopping anyone selling these devices on eBay – that doesn’t make it legal. The FDA doesn’t go around hunting down every eBay re-seller and taking them to court, it is simply not worth their resources. Instead they rely on the public and other organizations to report those that are selling devices without authorization.
What about countries outside the US?
As the rule does not apply to non-US countries, you may find that non-US Amazon and eBay websites market these devices. For example, in 2014 the EU’s ISO and CE bodies, as well as Health Canada cleared the device for sale over-the-counter.