***Information Below Now Longer Valid Though BEMER Reps continue to Say it ANYWAY!! They USED to be Class II registered which in all honestly is fairly restrictive. But BEMER tried to make a big deal of it. Now, they are ONLY class 1 just like iMRS 2000 and other respectable PEMF Devices!!
BEMER is NOT FDA Approved in the way drugs get FDA appoved, They Have FDA Class II Registration with 501K clearance. HUGE DIFFERENCE
A lot of Bemer reps claim that the Bemer Classic and Bemer Pro is FDA proved. The Bemer is simply FDA Class II registered and has 501K clearance, which simply means the FDA clears it for sale in the U.S.
NOTE: On FDA Approval... FDA Approval usually requires at least 5 years and 5 million dollars OR MORE to be approved for just ONE CONDITION. FDA Class II Registration takes less than a 1/2 year and not very much money. WORLDS OF DIFFERENCE. Also not that FDA approval puts several restrictions on a device, so it is not advantageous. For example, by prescription only, specific conditions only, etc. Besides being SO expensive, FDA approval also stifles innovation because if you upgrade or change your device, you have to apply for FDA ALL OVER AGAIN.
But it is a moot point because BEMER is not FDA Approved.
Don't be fooled, BEMER is NOT FDA APPROVED for ANY condition, they are Class II registered.
The BIG Problem for BEMER
According to the FDA paper, their system is now only approved with the following claims:
1) To temporarily increase local blood circulation in healthy leg muscles 2) To stimulate healthy muscles in order to improve and facilitate muscle performance
Their product Code with the FDA is NGX, which, if you read the description below is a muscle stimulator and conditioner. The description also says the following: this device is NOT intended for use in patients with medical conditions.
I do NOT understand this move from BEMER at all as they restrict themselves to (Clickable Link #3), no more medical related claims at all!!
Read this carefully, because Bemer has restricted themselves more than helped themselves. The truth is any company can complete this process, but it is not desireble for obvious reasons if you read the fine print.
Bottom Line: BEMER has no PEMF resonance device anymore, it became just a muscle stimulator…
Link 1 - Stimulator, Muscle, Powered, For Muscle Conditioning
The description also says the following: this device is NOT intended for use in patients with medical conditions. So if you have a medical condition, you are NOT SUPPOSED TO USE IT!! This is straight from the FDA website. The BEMER IS INTENDED ONLY FOR MUSCLE CONDITIONING PURPOSES!!