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. Even though the Fisher Wallace Simulator’s safety and effectiveness has been proven in numerous clinical trials and over decades of use, it still remains under Class III. However after considering new evidence, the FDA has recently proposed a reclassification to Class II.
Does this mean I have to go to my Doctor to get a prescription?
Fortunately, 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 in seconds. Following this, you can then complete the purchase on the website and have it shipped to you in no time. Alternatively, you can download the offline form and have it signed by your Doctor or Medical Professional.
What about other websites?
The same rule applies for anywhere in the US and any third-party provider must have provisions for resale.
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.