Are you looking to buy a PEMF device?
It’s an important step in your well-being, and you naturally want to ensure you get the safest, best quality device for your health and money.
One of your first questions is likely about how the FDA labels PEMF devices.
You’ll need to know three terms: FDA registration, FDA approval, and FDA clearance. Let’s go over each.
FDA Labels And PEMF
The FDA offers two services for PEMF devices: registration and approval.
While many consumers often use the terms interchangeably, they actually represent two very different processes.
Be aware that PEMF registered devices and PEMF approved devices are two separate classes of devices.
Many manufacturers commonly tout that their product/device is FDA registered.
It’s a fact that’s designed to offer the customer an assurance from an official body that the device is legitimate or safe.
In reality, an FDA registered device simply means that the agency is aware that the particular device has been imported into the country.
All imported medical devices, including PEMF equipment, must go through the FDA registration process.
However, FDA registration does not equate to any quality, efficiency, or safety guarantees to the consumer.
FDA approval is an altogether different process with a very different context and meaning.
Approval from the FDA is an earned title. The device must be proven to have health benefits.
It must also demonstrate that it can treat specific health condition(s.)
Then, the device’s benefits must be greater than the potential risks associated with its use.
Neurostar is an example of a PEMF device that’s FDA approved.
This high-intensity PEMF device is used to treat depression.
It should be noted that even FDA approval isn’t an infallible guarantee of safety, efficiency, or quality.
Why?
With consumer use, unknown or unforeseen safety risks can always emerge after FDA approval.
In such cases, the FDA can withdraw its approval.
It should also be noted that FDA approval is a lengthy and costly procedure.
Some manufacturers simply can’t afford or don’t value the FDA’s stamp enough to go through the process.
A manufacturer may be unable or unwilling to get approval for niche and branding reasons.
With PEMF equipment, this is often due to the device not being condition-specific, such as the Neurostar is used in specifically treating depression.
However, it may also be because the manufacturer doesn’t want to limit or confine their product in such a way.
PEMF has been extensively researched in treating an array of pathologies in the human body.
So, limiting the device to one specific use, health condition, and benefit is actually a great disservice to the device, its brand, and its potential consumer.
FDA Labels
Medical devices fall under three classes based on the control necessary to assure the safety of the device.
The FDA determines the consumer risk, level of invasiveness, and impact to the consumer’s wellness.
This is done by reviewing independent data max The agency then grants the appropriate class:
- Class l – This class represents almost half of all medical devices. It’s the lowest risk devices and drugs. Examples would be devices like an electric toothbrush, hospital bed, and medical bandages.
- Class ll – These are devices with a slightly elevated risk, often due to the length and type of exposure to the device. Examples would include contact lenses, blood pressure cuffs, and pregnancy tests. Most PEMF devices fall into this tier.
- Class lll – Only around 10 percent of all medical devices find themselves in this category. It’s reserved for devices with a high risk to the consumer, such as implants, pacemakers, and certain ventilators.
FDA Registered Devices
Devices that fall into the first class are given the FDA registered label.
These devices pose relatively no health risk, which means the FDA does not feel the need to test or vet the product.
The product’s manufacturer simply informs the FDA of the product’s existence.
The FDA then lists it as a registered product.
Consumers must be very careful in determining the status of a product and understanding the difference between a PEMF registered vs approved product.
Despite some clever marketing on the part of the many brands, FDA registered devices do not have any backing by the FDA in relation to testing, safety, guarantee, or any other such claims.
FDA Approved Devices
The third category is for devices that have been FDA approved. It’s a much involved process.
The device undergoes comprehensive testing to measure benefits against potential and known risks.
Only products that prove their benefits outweigh those risks become FDA approved.
As a consumer, you’ve likely noticed that many supplements and devices are very careful with their marketing wording and disclaimers. Instead of a specific health claim, they use wording like “health promoting.”
These products fall into the second category, and FDA approval is not mandatory.
However, if you note that a medical device claims that it can cure/treat a specific medical condition, then you can almost guarantee that it falls into the third class and must have FDA approval to make such claims.
What Does FDA Cleared Mean?
This term is associated with the second class of medical devices.
It means that the manufacturer has provided proof that the device is similar in effect and safety (equivalent) to a device that already exists, benefits outweigh risks, and no claims are made to cure/treat any medical condition.
The comparative device is one that’s already been cleared by the FDA.
Why Does FDA Classification Matter?
The FDA is responsible for protecting public health by regulating the medical devices used by consumers and patients.
This regulation is largely risk-based, and, in the case of class three devices, science-backed.
Knowing how the classification system works and where a particular PEMF devices falls along those tiers will help you in vetting your product and in knowing to what degree any claims have passed through regulations.
Do keep in mind that a device falling under FDA class one or two doesn’t automatically equate to a device being ‘lesser.’
If a device’s safety risk is low, for example, then it naturally wouldn’t need to be in a more rigorous tier.
The same can be said for PEMF devices not wanting to limit their plethora of benefits to only one purpose, which is why so many PEMF devices are class two devices.
With the above said, FDA classification shouldn’t be your only vetting component in selecting a PEMF device.
The innumerable class action lawsuits against medical device and drug manufacturers offer the prime example of how bad apples slip through the regulatory cracks.
This is why consumers should continue onward to view independent third-party clinical testing and validations for themselves as they select their PEMF device.