Safety

Do you care whether the sleep technology you are considering is safety certified or has been cleared for sale by the FDA? Consider this; it’s called SAFETY certification for a reason. If a technology has not been certified as safe by an internationally recognized organization why would you use it?

In November 2013, the Parent Company of the SomniResonance SR1 was informed the SR1 device had passed Underwriters Laboratories rigorous safety testing and was granted Medical Equipment Safety Certification number E464228.

In October 2014, the Company submitted an application to the FDA to be allowed to market the SomniResonance technology in the United States. In February 2015, notice was received from the FDA informing the Company the SR1 had been classified as “low risk” and that it had been cleared for sale in the U.S. The Company was also advised it could sell the device directly to the public for the treatment of sleep disorders without any requirement for a healthcare professional prescription or written recommendation.

Anyone considering purchasing a medical device should review the safety certification and FDA clearance or non-clearance of devices being considered.

A number of companies make “claims” in their promotional material but then have a “disclaimer” stating “they are not making medical claims, real or implied, as to benefit of their device and methods. Their product is not intended to be used to diagnose, treat, cure or prevent any disease”…or “their device is for experimental use only”.

The SR1 is cleared to make claims regarding sleep disorders. The SR1 is cleared by the FDA to treat sleep disorders.

The SR1 generates a magnetic field strength of 50 milliGauss. This is a natural field strength and is around the average field strength of the Earth (25-65 milliGauss). Other technologies utilize an unnatural field strength of over 1 Tesla. 10,000 Gauss = 1 Tesla meaning, technologies utilizing 1 tesla are 200,000 times stronger than the SR1. This is well outside the realm of a low risk technology.

The SomniResonance SR1 has been designed specifically and only to treat sleep disorders. Many years of research led to the development of the frequency pattern used by the SR1 to mimic the natural activity of the brain in falling asleep. The SR1 does not provide any unnatural magnetic field strength or frequencies.

The frequency pattern of the SR1 is designed to run for only 22 minutes. If the user has not fallen asleep in that time or if they waken during the night they can press the ON button for another 22 minutes. There is no health risk in switching the device on multiple times.
The frequency pattern is designed to allow the user to cycle through all of the natural stages of sleep. It is not designed to abnormally hold the user in any one stage.

The SR1 is a small, FDA cleared, UL Certified, battery operated, safe, non-invasive technology designed specifically to treat sleep disorders.