Miami, Florida - The US Food and Drug Administration has granted approval to Non-Invasive Monitoring Systems, Inc. (NIMS) to market its Exer-Rest as a Class I (exempt) therapeutic vibrator. The appproval covers intended use "as an aid to temporarily increase local circulation to provide temporary relief of minor aches and pains, and local muscle relaxation," as announced by Marvin Sackner, chief executive officer of NIMS in a 2 Feb 2009 statement.
This approval "provides the potential for our medical device to make a major impact for symptomatic relief of conditions that affect approximately 50 percent of the population," commented Steven Mrha, chief operating officer of NIMS, in the company's announcement.
Exer-Rest consists of a single or twin bed base fitted with a memory foam mattress, with the additional ability to produce 'Whole Body Periodic Acceleration [vibration] (WBPA),' to a person lying on the mattress. This vibration is achieved by repetitive head-to-foot movements, at a rate of about 140 times per minute over 30 - 45 minutes, said NIMS.
The movement comes from a patented motorised platform, whose speed, distance and time can be adjusted by a wireless digital controller. WBPA treatments are typically administered daily, five to seven days a week, for symptomatic relief, with the technology is protected by four US patents, said NIMS.
NIMS' submission to the FDA included 23 studies on the effect of WBP on vasodilation to improve blood flow, as well as the results of a controlled, four-week clinical trial in a group of patients with chronic aches and pains, at the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania Medical School.
NIMS is also licensed to sell Exer-Rest in Canada, the European Union and other major world markets. Exer-Rest is regulated as a Class IIa medical device with CE certification outside the US, the company said. Major interest from the Middle East and Africa followed ademonstration of Exer-Rest at the Arab Health conference in Dubai, NIMS added, saying it began shipping the product to Abu Dhabi and Turkey inDecember 2008.
The device can be used without assistance and NIMS expects it to be installed in homes, spas, wellness centres, workplaces, clinics, assisted living centres, nursing homes and hospitals.
PIC Testing the Exer-Rest at Electro Technical Products Inc. of Palm Beach, Florida, who helped NIMS develop the device. Pic courtesy of Thomas Peterick of ETP.
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