The AVACEN 100 is FDA-cleared for marketing in the United States for the temporary relief of joint pain associated with arthritis; and muscular relaxation. In 2017 the AVACEN 100 received the CE Mark and Health Canada approval adding widespread fibromyalgia pain management for the EU and Canada. A recent peer-reviewed clinical efficacy study published in 2017 reported that out of 22 patients evaluated, those who received the AVACEN 100 device treatment for 15 minutes twice a day demonstrated an overall reduction of more than 40% in their widespread pain index scores after 28 days. Out of these subjects, 93% reported a reduction of 29.4% or more in widespread pain index scores. Also, 62% reported a lower tender point count of two or more points while 57% reported a reduction of 20% or more in overall symptom severity score rating. With more than 2 million uses there has been no report of an adverse effect, which shows that the device is extremely safe and reliable.
Validated through a study conducted by The Department of Veteran Affairs and the University of California, San Diego between 2001-2013. Results demonstrate that ATM significantly reduces the widespread pain associated with FMS - 20 times more effectively than FDA approved drugs. The Avacen is NOT CLEARED FOR FIBROMYALGIA AND IS ONLY cleared in the US only for "The temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; and muscle relaxation."
AVACEN ® 100 Pain Relief Machine! Merely Released! FDA Cleared!
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U.S. FDA-Clearance: The AVACEN 100 is FDA-cleared as a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis; muscle spasms; minor strains and sprains; muscular relaxation; and the temporary increase of local circulation where applied.
Anthony Shimkin is the President and Chief Executive Officer of AVACEN Medical. AVACEN is a leading manufacturer of noninvasive, drug-free, FDA-cleared diagnostic and therapeutic medical devices designed to identify cardiac issues and treat pain resulting from numerous chronic and acute conditions, including the temporary relief of minor muscle and joint pain and stiffness associated with arthritis and potentially other conditions that can cause joint pain. Since Shimkin joined the company in May 2022, AVACEN has launched three new products while moving up the Inc. 5,000 list 761 positions to no. 1,480. 2ff7e9595c
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