SCENAR and the FDA

In 2002, the FDA accepted the SCENAR into the country as a Class II Medical Device used for biofeedback and muscle relaxation. From what I understand, FDA approval can be gained in two ways: (1)the device is developed in this country and the developers conduct studies and research as to its efficacy which is submitted to the FDA for approval, or (2) a device from another country can be shown to have the same action and effect as a device developed and previously approved in this country.

RITM OKB ZAO is the company that manufactures the RITM SCENAR for Dr. Alexander Revenko who was one of the two lead researchers in the development of the SCENAR in the Russian Space Program. This company applied for approval from the FDA by showing that it is essentially the same machine as the InterX5000 that was developed by Neuro Resource Group, located in Plano, Texas. Appropriate research and studies were conducted by NRG and their device was approved by the FDA. RITM OKB ZAO was able to show that the RITM SCENAR that they originally developed and began manufacturing in 1980 is the same device as the Interx5000 and was granted FDA approval on that basis on May 28, 2010.

Now that the RITM SCENAR is FDA approved, there are new requirements that must be adhered to:

1) To purchase a RITM SCENAR for home use, a prescription from a licensed MD must be obtained. The downside is that few MDs have any awareness of the device, so until they are educated, getting a prescription may be difficult. The upside is that with FDA approval, the purchase of the device may be covered by insurance, which may make it worth your while to educate your doctor yourself in order to get a prescription.

2) Previous to FDA approval, one could purchase a RITM professional device, get trained on it (which can be expensive and difficult to arrange), and then set up an office and practice. Since FDA approval, only those with licenses in the medical field such as MDs, Physical Therapists, Biofeeback practitioners, Massage Therapists, etc., can set up offices to provide SCENAR therapy. If you don’t have a license, you must still be trained and experienced in using the SCENAR, but you can only provide SCENAR treatments in the offices of those who are licensed.

Healing Innovations uses the RITM SCENAR device. Our practitioners are trained at the Advanced Level by Dr. Alexander Revenko, have 6 years of experience, and work in the offices of those who are licensed in the medical field. Call us at 828-337-6854 and let us see what SCENAR can do for you.

1 Comment

• 

  By Sandra, October 31, 2011 @ 12:52 pm

  Would a Reiki master license or certificate work to set up an office and practice for SCENAR therapy?

Other Links to this Post

RSS feed for comments on this post. TrackBack URI

Leave a comment