FDA Approved vs FDA Registered PEMF Devices

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.

 

How Does the FDA Grant Its Labels?

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:

• Class 1 – These are very low-risk devices and drugs. For example, dental floss and bedpans fall into this category.
• Class 2 – These devices have a higher risk than Class 1. Condoms and pregnancy tests fall into this category.
• Class 3 – These devices present a very high risk to human health. For example, pacemakers and heart valves are placed in this category.

So, to explain further about FDA registration and approval, we had to learn about these classes.

 

FDA Registered

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.

 

FDA Approved

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.

 

FDA Cleared

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.

 

PEMF Health Benefits

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.

• Accelerated postsurgical recovery. PEMF treatment can greatly reduce the pain and swelling that occur after plastic surgery. This was proven in a study completed by the NIH in 2009 and published in the Aesthetic Surgery Journal. (1)
• Decreased back pain. In another study completed by the NIH, results show that patients who suffered from failed back surgery syndrome experienced relief after receiving PEMF treatment. The study was published in the International Medical Case Reports Journal. (2)
• Improved range of motion. Patients suffering from cervical osteoarthritis can benefit greatly from PEMF treatment. PEMF reduces the pain that these patients feel and increases their range of motion, as a 1996 study shows. (3)
• Decreased pelvic pain. Patients suffering from gynecological issues that are causing chronic and acute pelvic pain can find relief in PEMF treatment. As a 1993 study shows, PEMF therapy greatly reduces pelvic pain in these instances. (4)
• Accelerated nerve repair. In 1993, a study was sponsored by the Bioelectromagnetics Society and reported by the NIH. The study found that PEMF treatment could promote healing of sciatic nerve damage by 22%. (5)
• Eases depression. In a study conducted on rats in 2000, the findings showed that PEMF treatment significantly decreased feelings of fear and anxiety in rats. The results of the study were reported by the NIH. (6)
• Improves sleep. PEMF devices can be used to support our bodies’ circadian rhythm. Lower frequencies can help calm the body and mind, and prepare us for sleep. It has been proven that using a PEMF device before sleep allows us to enter the REM phase much faster, and to stay in that phase longer.
• Reduces stress. Stress is a condition from which a lot of people suffer today, and it can trigger some more serious health conditions like heart issues, diabetes, immune system crashes, and so on. Lower frequency PEMF treatment can reduce the secretion of the stress hormone (cortisol), and in that way greatly reduce the stress that we feel on an everyday basis.
• Enhanced sports performance. PEMF devices are known to improve blood flow in targeted areas through the process of vasodilatation. The body can thus recover much faster from strenuous physical exercise by expelling lactic acid more efficiently, and recover from muscle fatigue much faster as well.