In this article we will explain what is the difference between FDA approved and FDA registered PEMF devices.
If you are looking for a PEMF device, please read this article where we compare the best PEMF devices currently available on the market.
There are two services that the FDA provides that concern us when it comes to PEMF devices: FDA registration and FDA approval.
What are these?
We should not confuse PEMF registered and PEMF approved devices.
Quite often, manufacturers boast that their product is FDA registered, hoping the customer will see that as a form of reassurance.
However, if a PEMF device is FDA registered, it only means that the FDA is aware of the fact that this device is imported into the USA.
It is by no means a guarantee of safety, efficiency, or quality.
All medical devices imported into the U.S. need to be FDA registered.
On the other hand, FDA approval needs to be earned by proving that a PEMF device has health benefits, that it can be used to treat a specific health condition, and that the benefits outweigh possible risks.
Most often, very high-intensity PEMF devices are FDA approved, such as the Neurostar, which can be used to fight depression.
However, this is not a bulletproof guarantee of quality, since the FDA sometimes withdraws its approval for safety reasons.
It should be said that many manufacturers do not want to earn FDA approval.
This is because this stamp is quite expensive, but also because, in that case, a PEMF device needs to be condition-specific.
However, PEMF devices treat a wide range of health conditions, so it would do a disservice to them to limit their benefits in such a way.
The FDA decides which label to grant to a medical device, depending on the level of safety risk it presents to patients.
There are three main classes of medical devices according to risk:
So, to explain further about FDA registration and approval, we had to learn about these classes.
The ‘FDA registered’ label is given to medical devices that fall into the first category.
Since they present little or no health risk, they do not need to be tested by the FDA in any way.
The FDA registration simply means that the company has let the FDA know about this product, and that the FDA has ‘listed’ it.
This is no guarantee of safety or efficacy, even though many companies try to claim such a thing and collect marketing points that way.
On the other hand, the ‘FDA approved’ label is much harder to get, and it is given to medical devices that fall into the third category.
In order to become FDA approved, a medical device needs to undergo a rigorous testing process, and prove that its benefits far outweigh its risks.
Only about 10 percent of all medical devices fall into this category.
The rule of thumb is that if a medical device claims that it cures a specific illness, it will need FDA approval.
That is why many devices and supplements claim that they only ‘promote health,’ and in that case fall into the second category, and do not need FDA approval.
Class 2 medical devices only need to be cleared by the FDA.
This means that the FDA will not test them itself, but the company needs to provide proof that the device is similarly effective to an already existing device on the market that claims to do the same thing and has already been cleared by the FDA as effective and safe.
The company also needs to prove that the device has more benefits than risks, and cannot claim that it cures any specific health condition.
We have known about the benefits of magnetic fields for more than 4000 years; however, most of that knowledge was acquired on a trial and error basis.
In the middle of the previous century, scientific advances allowed us to describe the benefits of pulsed electromagnetic fields in a more systematic and scientific way.
Since then, we have learned a lot about the applications of PEMF devices, but also about which frequencies work best for specific health conditions.
Here are the most common health benefits about which we know so far.
Richard Hoover is a PEMF expert and content contributor to PEMF Advisor. With a bachelor’s degree in physics and multiple certifications in natural health programs, he is one of the best PEMF experts around.
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