The FDA sent a warning letter to Non-Invasive Monitoring Systems Inc. (OTC:NIMU) alleging that the company markets its therapeutic vibrator for uses not approved by the federal watchdog agency.
The Miami, Fla.-based company’s Exer-Rest “whole body periodic acceleration system” is a Class I exempt device, according to the company, meaning it doesn’t need to undergo the pre-market studies required for 510(k) clearance or the more rigorous pre-market approval process for medical devices.
But the FDA claims the company is marketing the device for indications that would require both types of approval. A device qualifies for "Class I" exemption "when it is intended for relaxing muscles and relieving minor aches and pains," according to the FDA’s letter. The warning notes that the company website’s "Study Support" section indicates that the Exer-Rest "may be used during CPR, as ‘cardioprotective preconditioning,’ for brain damage reduction in ischemic strokes, for asphyxia, for enhancing brachial endothelial function, for cardiovascular disease, for asthma, and for fibromyalgia."
The FDA ordered the company to immediate remove the offending language from its site.
The "Study Support" section of the company’s website no longer lists the information that the FDA took issue with, but a March 9 cached copy of the webpage on Google’s servers includes the statement "Science supports Whole Body Periodic Acceleration for safe and effective therapy," which is followed by six studies on the device involving CPR, each of which is still stored on the company’s server.
NiMS inked a deal in September 2009 with the Naval Medical Research Center in Silver Springs, Md., to evaluate the Exer-Rest for patients with traumatic brain injury.
The release describes the Exer-Rest as an "FDA listed medical device intended as an aid to temporarily increase local circulation, to provide temporary relief of minor aches and pains, to reduce morning stiffness and to provide local muscle relaxation." The Exer-Rest is also approved in the United Kingdom, European Union, Canada and Mexico "as an aid to increasing circulation and for increasing joint mobility," according to the company.
