Is The Bemer Mat Fda Approved

For more information click here for the fda site.

Is the bemer mat fda approved.

You can find this information on the fda website. Bemer fda approval as commonly referred to online is actually what is known as an fda registration via the fda 510 k form. Here is an explanaition on how devices get fda approval. Fda class 1 510 k ce certification.

Certification and classes. Both imrs and bemer are fda registered. Our products are designed to comprise a complete complementary solution for improving your well being. As a bemer user i have one signalling device and 2 applicators to choose from.

It is not recommended for use for any medical condition. It s important to differentiate between fda approval and fda registration. Bemer devices are the perfect personal and professional adjuvant solution for the discerning everyday user. Bemer products are fda registered not fda approved as a class 1 medical devices with 510 k clearance.

Bemer therapy systems 510 k premarket notification k151834 bemer international ag page 6 1 2 22 17 6. Bemer classic set bemer pro set. In 2011 the fda approved pemf therapy for treatment of brain cancer. Is bemer fda approved.

510 k summary the following information is provided as required by 21 cfr 807 92 for bemer international ag s bemer therapy systems 510 k premarket notification. Bemer is an fda class 2 registered device for muscle stimulation. Bemer mat bemer group may be the most recognized name associated with pemf therapy as the company has been around since the 1990s. So to a answer the question yes it is bit it class i.

On october 13th 2015 the fda reclassified pemf devices from their existing class 3 category to a class 2 status and most pemf devices that are sold today in the united states are fda registered. To start off with bemer mats are certified by the following. 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. The fda may or may not require supporting research.

Stimulator muscle powered for muscle conditioning. When a device is registered this means it simply fits into a category of devices the fda has already decided is safe. Bemer is an fda class ii cleared consumer medical device that is non invasive and easy to use. Stimulating healthy muscles and temporarily increasing blood circulation in healthy leg muscles is the primary goal of bemer to support muscular health and optimize performance.