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FDA clears Zynex InWave urinary incontinence device

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Zynex's InWave device, designed for treating female urinary incontinence.

Following the approval, the company said the InWave device will be manufactured, marketed and sold by its subsidiary, Zynex Medical.

Zynex CEO Thomas Sandgaard said the InWave, which has reimbursement facility by health insurance, is the new addition to the company’s broad product line.

"We believe it will provide our expanding sales force an additional tool to fuel revenue generation in our rapid growing Zynex Medical subsidiary," Sandgaard added.

Patients having urinary incontinence usually suffer with involuntary loss of bladder or bowel control, the company said.

In addition to incontinence devices, the company is involved in developing non-invasive medical devices for electrotherapy, stroke rehabilitation, neurological diagnosis and cardiac monitoring.