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SEPTEMBER 6, 2024

FDA Clears TENS Device for Pain Management

The FDA has cleared the use of the noninvasive medical device TensWave (Zynex) for pain management and rehabilitation indications. 

The portable device uses transcutaneous electrical nerve stimulation (TENS) to reduce both chronic and acute pain without the use of medication.

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"The introduction of TensWave aligns perfectly with our commitment to providing comprehensive pain management solutions," said Thomas Sandgaard, the CEO of Zynex Medical. "We recognized a gap in the


The FDA has cleared the use of the noninvasive medical device TensWave (Zynex) for pain management and rehabilitation indications. 

The portable device uses transcutaneous electrical nerve stimulation (TENS) to reduce both chronic and acute pain without the use of medication.

"The introduction of TensWave aligns perfectly with our commitment to providing comprehensive pain management solutions," said Thomas Sandgaard, the 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 multimodality 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."

The TensWave device is not intended to replace the NexWave electrotherapy device, according to the company in a press release. Instead, it is a complementary product “that can provide flexibility in dealing with patients' insurance coverage,” for individuals whose insurance plans exclusively cover TENS therapy. 


Based on a press release from Zynex.


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