PEMF therapy is increasingly popular.
A glance through the marketing materials for PEMF therapy machines reveals the claim that some PEMF therapy machines are FDA approved, while others are not.
Are PEMF therapy machines approved by the Food and Drug Administration?
First, let’s take a look at FDA approval requirements, and the different levels of involvement FDA approval can have.
FDA Approval Requirements
Although the FDA is not as stringent an organization as many of its international peers, there are still some hard and fast rules that must be followed in order for a device or a technology to receive an approval from the Food and Drug Administration.
The most pressing requirement is that of proof: if an item, device, or technology does not have adequate proof to suggest that it does what it claims to do, it will not be pushed through for FDA approval.
If it does, it may be given FDA approval.
In addition to proving that an item does as it claims, people in search of a Food and Drug Administration approval must demonstrate how and where the item is being constructed, and how the item is being marketed.
Provided that all of these elements are in place and the appropriate applications have been filed, an item, technology, or device can receive FDA approval.
The process can be short, but can also be lengthy, and there have been plenty of items and technologies that have spent more than a year (or even longer) awaiting FDA approval.
FDA approval is also dependent upon the purpose of a device or technology.
In the case of PEMF therapy, FDA approval is not required.
Although certain machines, like an MRI machine, are used specifically in clinical settings and hospitals and pose a significant risk to health, devices like PEMF therapy machines do not pose a serious hazard and therefore do not require the intensive application and approval process that potentially hazardous machines and materials do.
PEMF therapy devices are considered wellness devices, and therefore do not require the “stamp of approval” from the FDA.
Approval Vs Registration
Many PEMF therapy companies will list their device as being “FDA Registered”.
The reasons for this are twofold: the term can be used to mislead consumers, as they may see “FDA” and assume that the product is approved by the FDA, but can also be used to let consumers know that the FDA is aware of the product being used and/or imported in the United States, without a record of wrong-doing or issue.
Although the two terms are frequently mistaken for one another, they mean two very different things.
FDA approval, as identified above, involves proof that the device in question achieves what it is supposed to, and what it claims to do.
FDA registration simply means that the device is following the proper channels to be used in or imported into the United States.
All PEMF therapy devices must be FDA registered in order to clear customs or be distributed through appropriate channels in the United States.
PEMF and FDA Approval
It would seem that PEMF therapy devices have an FDA approval, but this is not the case: rather than approving a specific PEMF machine, the FDA approved PEMF therapy.
To put this in another context, consider the following: physical therapy is approved for use in rehabilitating bone breaks, but the different techniques themselves do not bear seals of FDA approval.
PEMF therapy is similar, in that PEMF therapy as an entity is approved for several uses by the FDA, but the individual machines do not have their own stamps of FDA approval.
Several companies have laid claim to this, because their machine was used in a trial for FDA therapy, but the machine itself was not a consideration in the trials used to determine FDA approval; the therapy itself was considered and, ultimately, approved.
What exactly has been approved by the FDA?
As it turns out, even though there are new and emerging research studies supporting the use of PEMF therapy, there are actually numerous different ailments that have already received an FDA approval.
These uses include depression (and specifically treatment-resistant depression), muscle stimulation, non-union fractures, and even tumors.
PEMF therapy was approved for these uses specifically because the FDA determined that there was ample evidence to suggest that PEMF therapy devices effectively targeted these conditions and made a difference in their progression.
Are Any Devices FDA-Approved?
Despite what some marketing materials might have you believe, there are no PEMF therapy machines that currently bear the mark of FDA approval.
This is because the FDA approval is based on the performance of the therapy, rather than individual machines.
As long as machines utilize the technology unique to PEMF therapy, it is logical to determine that these machines perform PEMF therapy as specified by the studies utilized in the FDA approval process.
Many PEMF therapy companies use the term “FDA” as a hot-button word to grab the attention of consumers, and to suggest that their machine is either more legitimate or more effective than others.
In truth, PEMF therapy machines come in a wide variety of settings and designs, and provided that they create a pure electromagnetic field and subsequently apply that field to the body in pulses of energy, they are delivering the therapy that the FDA has approved for use in human and animal trials.
Which Machine Is Best?
Without the FDA stamp of approval as a guide, it can be difficult to determine which of the many PEMF therapy machines on the market is the best for your individual needs and your particular preferences.
There are two machines in particular that tend to stand out among the rest: the Bemer mat and the HealthyLine Platinum mat.
To provide a clear picture of how these machines operate and what sets them apart, we will look at each machine individually.
Bemer PEMF Therapy
The Bemer company is perhaps one of the most well-known PEMF therapy companies out there, with years of tried-and-true use.
Bemer machines utilize a pyramid structure in their pricing and distribution.
This pyramid is called multi-level marketing, and it is often responsible for significant hikes in price.
The multi-level marketing structure that Bemer uses makes it essential to increase prices, because the company has to pay both itself and the individual selling the product.
Although the Bemer company may not indicate that this is the case, many MLM businesses are significantly more expensive than their peers because of the structure and how many “middle men” the structure must pay.
Bemer PEMF machines come with 2-3 different applicators: a pad, a wrap, and a small, circular applicator.
The control box is limited in its scope, as it allows users to select from a series of pre-determined settings.
The company recommends eight minutes of use twice per day in order to improve sports performance, sleep quality, and cognition.
Although these numbers are not supported by the vast majority of PEMF therapy studies, the company site regularly suggests that two sessions of eight minutes will yield the best results.
HealthyLine PEMF Therapy
HealthyLine Platinum machines are newcomers when compared to Bemer machines, and differ in their components and methods.
Perhaps most significant are the delivery method and the controller.
HealthyLine Platinum machines come with a mat (different sizes are available) that can be used on a chair, bed, or floor.
The mat is designed to deliver PEMF therapy to as much of the body as possible in a single setting, rather than applying the therapy to a small, targeted area.
The HealthyLine controller also differs from the Bemer controller, in that it offers more creative freedom.
Users can select the different components of PEMF therapy to create their own unique setting “blends” according to their needs for that day or that particular session.
The controller associated with HealthyLine Platinum mats is one of the few controllers in the industry to offer such a wide range of options.
Bemer’s Famed Unique Qualifications
The Bemer company is one of the companies with marketing materials suggesting that its products are uniquely equipped to deliver PEMF therapy.
While it is true that Bemer machines possess all of the components necessary to deliver effective PEMF therapy, Bemer products are not substantially different from other PEMF therapy machines.
Bemer uses the same basic framework as other PEMF machines, with the same settings as most other PEMF therapy machines.
The waveform of Bemer machines is said to be what gives PEMF therapy its power—power that is said to stimulate microcirculation.
In truth, PEMF therapy as a whole is capable of stimulating circulation (including the circulation terminating in the body’s capillaries).
The hefty price tag associated with Bemer machines is not necessary to secure a machine that effectively targets and stimulates circulation.
Many people trust Bemer machines because the company is one of the oldest PEMF therapy companies that is still seeing use.
Fortunately, there are increasing numbers of PEMF therapy companies that offer the same high-quality PEMF therapy at a fraction of the cost associated with Bemer.
These machines frequently offer additional therapies that can be used in conjunction with PEMF therapy, allowing consumers to purchase a machine with more options and more customization abilities with a smaller budget.
HealthyLine’s Unique Approach
HealthyLine Platinum machines are unique in the world of PEMF therapy, because they offer numerous different therapies in a single machine.
While some machines offer PEMF therapy with one other option, such as Far Infrared (FIR), HealthyLine Platinum mats offer up to five different therapies in a single machine, at a fraction of the cost associated with the more expensive (and even middle-of-the-road) PEMF therapy choices.
HealthyLine Platinum mats offer five different therapy options: PEMF, FIR, crystal therapy, negative ion therapy, and photon therapy.
This approach allows HealthyLine Platinum mat users to receive the benefits of each of these therapies that, separately, could take up several hours each day.
With HealthyLine, customers can reap the benefits of each of these therapy options in a single, fell swoop, saving time, energy, and money.
HealthyLine is also unique, in that it affords its customers the most in customizable machines.
While many machines offer only a few predetermined settings (Bemer included), HealthyLine Platinum mats allow you to customize each setting on your machine.
The intensity, waveform, frequency, and the number of therapies can all be determined by the user, allowing you to create individualized sessions each time you use your mat.
Giving you the option to change the controls also allows you to determine which settings work best for your wants and your needs.
With some trial and error, you can determine the settings that most effectively target the issues you have and help you feel your best.
HealthyLine Vs Bemer
While many people feel that going with the oldest company is always a solid bet, this is not always the case and is certainly not the case with Bemer.
Older companies are more established, but that can lead to stagnation in design, exorbitant marketing costs, and more, all of which lead to machines that are perfectly functional but perhaps not invested in getting customers the most “bang for their buck,” or innovating to bring the best therapy options to the company.
Older can mean more reliable, but it can also mean less inclined to offer value to customers.
Whether these things apply to Bemer machines or do not is immaterial; what matters is finding the machine that works best for your needs, and offers a therapy experience that you can rely on, and that feels safe and functional for you.
HealthyLine machines offer the same basic therapy that Bemer and other, older companies’ machines offer, but with greater customizability, more options, and a significantly lower expense.
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.