FDA 510(k) Clears Zynex’s InWave Female Urinary Incompetence Device

In short

Zynex, Inc., a provider and developer of non-invasive medical devices for electrotherapy, stroke rehabilitation, neurological diagnosis and cardiac monitoring, announced that it received FDA 510(k) clearance on its InWave medical device which is designed to aid in the treatment of female urinary incompetence.


According to the U.S. National Association for Continence, urinary incontinence affects 200 million people world-wide, and it is believed that 80% of those sufferers are women. InWave is a TENS-based electrotherapy device designed primarily for treating female urinary incontinence and is the newest product in the Zynex portfolio which extends to pain management and rehabilitation applications.

Company comments

Zynex’s CEO, Thomas Sandgaard, commented; “We are very excited about the introduction of this new product. The InWave adds to our already broad product line and is reimbursed by health insurance. We believe it will provide our expanding sales force an additional tool to fuel revenue generation in our rapid growing Zynex Medical subsidiary.”

Source: Zynex, Marketwire