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NIMS Receives FDA Approval To Market Exer-Rest

Non-Invasive Monitoring Systems, Inc. (NIMS) announced that it has received the FDA approval to market the Exer-Rest as a Class I (exempt) therapeutic vibrator (K083128). The device has got approval for the intended uses "acts as an aid to temporarily increase local circulation, to provide temporary relief of minor aches and pains, and local muscle relaxation". Exer-Rest fitted with a memory foam mattress, has the configuration of a single or twin bed. The device produces Whole Body Periodic Acceleration [vibration] (WBPA) to an individual (who lies horizontally on the mattress) through repetitive head-foot movements at approximately 140 times per minute during a 30 to 45 minute session. The movements are obtained by a patented motorized platform which is adjustable for speed, distance and time through a wireless digital controller. Non-invasive, drug-free WBPA treatments are usually administered daily five to seven days a week for symptomatic relief. WBPA technology is protected by four US patents. In October 2008, NIMS has filed the 510(k) submission for Exer-Rest with the FDA as a Class I (non-exempt) therapeutic vibrator. The submission of Exer-Rest included 23 investigational and clinical studies on the vasodilatation properties of WBPA as well as a controlled, four week clinical trial in a group of patients with chronic aches and pains carried out at the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania Medical School.