Wearable, Non-Invasive Ultrasound Therapy Device Cleared by FDA
According ZetrOZ Inc, Trumbull, Conn, the US Food and Drug Administration (FDA) recently granted 501(k) clearance for the marketing of sam, the company’s ultrasound pain-management device. The non-invasive sam is a wearable, long-duration, ultrasonic diathermy device for use in deep therapeutic treatment. sam will be available by prescription, the company notes in a recent news release, and can be used to treat musculoskeletal and joint pain in adults. The long-duration, continuous ultrasound therapy product is cleared by the FDA for relief of pain, relief of muscle spasm, treatment of joint stiffness and increased local circulation.
George K. Lewis Jr, PhD, product inventor and company co-founder, explains that the device is designed to use “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.”
Lewis adds that the device is clinically proven to be an effective deep therapeutic treatment for select medical conditions, that “…when used daily, provides added therapeutic benefit for chronic pain patients.”
The device can reportedly be worn daily for up to 4 hours on a single charge, offering continuous pain relief or used as part of a rehabilitation program seeking to heighten local circulation of injured tissues for multiple hours. The company adds that the leadership team behind the device plans to launch sam by spring of 2014.
[Source: ZetrOZ Inc]