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ZetrOZ U.S. gets FDA Grants Clearance to Market a Wearable Ultrasound Therapy Device
This would be the First ever Non-Invasive Ultrasound Device Cleared by the FDA for Continual Drug-Free Pain Therapy
"The device uses high-frequency ultrasonic excitations to produce deep mechanical stimulation within the body, increasing circulation, reducing inflammation and pushing nutrients through the body's cellular structures,"
Sam® ultrasound therapy devices are rechargeable and can be worn every day for up to four hours on one charge, providing nonstop relief of pain or can be used as additional therapy to increase circulation of injured tissues for hours on end.
"The use of therapeutic ultrasound to treat a variety of conditions, including musculoskeletal pain, offers great promise to our patients," says Thomas M Best MD, PhD, Professor and Pomerene Chair, Division of Sports Medicine, Ohio State University. "In particular, this low intensity, iPod-sized, wearable, battery powered device and its early success in a series of pilot studies represent a breakthrough in our abilities to treat patients in a user friendly, convenient manner."
"Sixty-seven percent of those over 40 live with aches and pains," continued Dr. Lewis, who just conducted a national survey on pain management. "sam® has been proven to considerably reduce pain without the use of pharmaceuticals and could be the next generation of wearable tech to make a 'quality of life' advance for millions of chronic pain victims. Furthermore, the science around sam®, and the usefulness of miniature devices that provide long-duration therapeutic ultrasound, hold significant promise in the field of bioelectronic medicine."
sam® is available by prescription from licensed healthcare providers such as primary care, orthopedists, rheumatologists, pain specialists and physiotherapists in the United States. In Europe and Canada, sam® is CE-marked and licensed, respectively, and is available over-the-counter directly to the patients.
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