MIAMI -- Marvin A Sackner, M.D., Chief Executive Officer of Non-Invasive Monitoring Programs, Inc. [NIMS] (OTCBB:NIMU) declared that the FDA has granted approval to NIMS to market Exer-Rest as a Class I (exempt) therapeutic vibrator with the next intended utilizes: "as an aid to briefly maximize community circulation, to offer you short-term relief of slight aches and pains, and neighborhood muscle rest." Exer-Relaxation has the configuration of a single or twin bed and is fitted with a memory foam mattress. This healthcare gadget delivers Full Physique Periodic Acceleration [vibration] (WBPA) to an man or women (who lies horizontally on the mattress) because of repetitive head-foot movements at about 140 times per moment while in a 30 to 45 moment session. The movements are obtained by a patented motorized platform which is adjustable for velocity, distance and time by a wireless digital controller. Non-invasive, drug-at no cost WBPA therapies are in general administered day to day five to seven days a week for symptomatic relief. WBPA engineering is guarded by four US patents.
NIMS filed the 510(k) submission for Exer-Rest with the FDA as a Class I (non-exempt) therapeutic vibrator in October 2008. The submission provided 23 investigational and medical reports on the vasodilatation properties of WBPA as perfectly as a managed, 4 week medical trial in a group of individuals with persistent aches and pains carried out at the Middle for Medical Epidemiology and Biostatistics at the University of Pennsylvania Medical related School. This submission supported Exer-Relaxation security and efficacy for the intended takes advantage of and FDA granted approval as a Class I (exempt) therapeutic vibrator (K083128). NIMS will supply Exer-Relaxation units for dwelling healthcare this month.
NIMS, an ISO 13485 licensed service, is also licensed to sell Exer-Relaxation in Canada, the European Common Market place and other leading entire world markets. Exer-Relaxation is regulated as a Class IIa clinical system with CE certification exterior the US.
Steven Mrha, Chief Operating Officer of NIMS, stated that "FDA approval to industry the Exer-Rest allows for the opportunity for our medical system to make a significant effect for symptomatic relief of situations that impact about 50% of the population. Exer-Rest is made to be put into use with no need of have for third celebration guidance and can be put in in the dwelling, spas, wellness centers, workplace, clinics, assisted dwelling centers, nursing homes and hospitals. In addition, NIMS options to set up demonstration centers in Miami and Toronto in the 2nd quarter of 2009 where by the two healthcare pros and non-public individuals can practical knowledge the many benefits of this new, novel engineering." Mrha additional that "In January 2009, NIMS exhibited Exer-Relaxation at theArab Well-being conference in Dubai exactly where it produced a awesome offer of interest from individuals, healthcare experts and health-related merchandise distributors residing in the Middle East and Africa." NIMS commenced delivery Exer-Restunits to Abu Dhabi and Turkey in December 2008.
Safe and sound Harbor Statement: Under the Private Securities Litigation Reform Act of 1995: The Statements which are not historical facts contained in this press release are ahead-trying statements that involve particular challenges and uncertainties together with but not constrained to risks involved with the uncertainty of long run personal outcome, added funding needs, progress of new services, government approval processes, the affect of aggressive items or pricing, technological improvements, the influence of economic conditions and other uncertainties specific in the Company's filings with the Securities and Trade Commission.
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