FDA OKs Zynex’s TensWave Pain Management Device

Zynex, a company focused on non-invasive devices for pain management and rehabilitation, has obtained U.S. Food and Drug Administration (FDA) clearance for its new TensWave device.
 
The device provides pain relieve through TENS (transcutaneous electrical nerve stimulation), which has been clinically proven to reduce chronic and acute pain without needing medication. The TensWave device, according to Zynex, has a user-friendly, portable design that can be easily worked into patients’ routines.
 
Zynex believes TensWave will become an essential tool for patients with chronic pain conditions. It could offer a safe, effective, drug-free alternative to manage pain. TensWave complements the company’s electrotherapy products, cervical traction, braces, cold/hot therapy, and compression devices.
 
The company noted that TensWave isn’t intended to replace its NexWave electrotherapy device, which remains a solution for patients seeking comprehensive electrotherapy. Zynex said TensWave is a complementary product for those whose insurance plans exclusively cover TENS therapy.
 
“The introduction of TensWave aligns perfectly with our commitment to providing comprehensive pain management solutions,” said Thomas Sandgaard, CEO of Zynex Medical. “We recognized a gap in the market for a high-quality TENS device that meets the specific criteria for insurance reimbursement, and TensWave is our answer to that demand. It complements our flagship multi-modality device, the NexWave, where Interferential current is the main modality and driver of obtaining prescriptions. This device broadens our product portfolio and enhances our support to patients.”