GyroStim and FDA

One of the questions we are often asked is:

What is GyroStim's status with respect to FDA clearance?

UltraThera Technologies, Inc., is the developer and manufacturer of GyroStim Balance Training System. GyroStim is designed to provide challenge and exercise to the human balance system.

GyroStim is currently marketed and sold as exercise equipment and is not intended to treat, prevent, or cure any disease, injury, or disorder. As such, GyroStim has not yet been cleared by FDA as a medical device.

We are aware that GyroStim is being used beyond the purpose of balance training exercises, and some applications of GyroStim have been for the therapeutic treatment of medical conditions under the guidance of a medical professional.

In light of this, UltraThera is currently in the process of preparing a submission to FDA with the intent to market GyroStim as a medical device. This process is a complex and costly endeavor.We are working directly with an industry leader in regulatory affairs to help us through this process as efficiently as possible.