Bemer therapy is not FDA approved, it is FDA registered, and approval and registration are not the same thing.
Whether this is important to differentiate is really up for individuals to decide for themselves, but the terminology of approved and registered is frequently interchanged without any acknowledgement of the differences.
The unbiased answer to the question of “Is Bemer Therapy FDA Approved?”, is that Bemer therapy is not FDA approved, but it is still registered with the FDA, has clearance to sell in the USA, and is safe for use.
See here the Bemer FDA Registration as we have displayed from a screen shot below.
Bemer FDA Approval
Bemer FDA Approval, as commonly referred to online is actually what is known as an FDA registration via the FDA 510(K) form.
An FDA 510(K) form allows the FDA to determine whether or not a device or product will fall into a category of devices which has already been reviewed by the FDA and deemed either safe or unsafe.
In the case of Bemer, they have submitted a 510(K) form to the FDA and the Bemer device has been categorized as a “Powered Muscle Stimulator”, as seen on the Bemer’s 510(K) Premarket Notification (screenshot below).
This is a category of devices which the FDA has approved as safe and as such the Bemer Group has been granted permission to sell and market their product in the USA, as seen in the FDA’s Response to Bemer’s Section 510(k) premarket notification.
What is a FDA 510(K) Form?
To help understand the difference between FDA Approval and FDA Registration, we’ll briefly explain what exactly the FDA 510(K) form is.
The FDA 510(K) form is a form that the FDA requires all brands and companies to submit before selling or even marketing their product in the USA.
This form is meant to streamline the clearance of devices to be sold in the USA, and this is done by rapidly categorizing devices into pre-existing categories, or if necessary creating a new category to be actually be approved.
Once a device is classified & registered into a pre-existing category, the only question is whether or not the devices in that category are safe for use.
If the device category is deemed safe, such as with the Bemer 510(K) form in the “Powered Muscle Stimulator” category, then it’s off to the races and the device is registered and ready to be sold and marketed in the USA.
All of this is publicly available on the FDA website, check out the FDA Response to Bemer’s 510(K) Form, we have taken a screen shot of the first paragraph below for you.
Bemer on FDA Import Alert List
The FDA keeps an import alert list of devices which they will detain without physical examination when they come in to the country.
It’s often updated and as can be seen below was last updated on March 10, 2020.
You can go to the FDA page here and make a search using CTRL and F buttons to search the term “Bemer” and find them on the list (as it is a very, very long list), FDA Import Alert List.
As you can see below, the Bemer’s 510(K) form may no longer be sufficient to overcome the appearance of violation, but what this violation we were unable to determine.
If you’ve been experiencing issues trying to buy a Bemer recently it is likely because all import of Bemer products into the USA have been recently as of October 17, 2019 halted.
Bemer MDC Marking
The Bemer also has the MDC marking certification on their devices.
The MDC stands for “Medical Device Certification” and is a European based company which independently reviews medical devices.
Companies and brands will pay the MDC to review their device in the hopes that they determine it as safe, and then can put the MDC marking on their devices.
To learn more check out the Medical Device Certification website.
Bemer CE Marking
The CE marking is another certification which is included on the Bemer devices.
The CE actually stands for European Conformity, and the C and E are backwards because this certification body is based in France and in French they say instead, Conformity European.
Companies are actually permitted to put the CE Marking on their devices without ever having their device reviewed.
They’re allowed to do so under the pretense that they declare that they meet all the regulations required to be approved by the CE.
The CE will review and certify a select number of devices, but only when companies request this.
We can tell whether a product was actually certified by the CE if a certification number is included with the CE stamp on the product.