Simulated Environment Concepts to Seek FDA Registration Approval

Food and Drug Administration’s 510(k) Registration Will Further Support SpaCapsule’s Penetration Into Health, Medical & Wellness Communities

MIAMI–(BUSINESS WIRE)– Simulated Environment Concepts (Pink Sheets:SMEV), the manufacturer and developer of medical, aesthetic and wellness equipment, announced today that they will file a 510(k) Medical Device registration application with the U.S. Food and Drug Administration to further enhance the company’s flagship product, SpaCapsule, and its PT (Physical Therapy) model, PTJetCapsule.

“We can easily continue to operate within the commercial markets without registration with the FDA,” stated Dr. Ilya Spivak, Marketing Director of Simulated Environment Concepts (SE Concepts) and co-inventor of the SpaCapsule. “However, as a proper gesture, a company manufacturing medical grade and aesthetic devices for health, medical and wellness communities, we should seek an appropriate acknowledgment from the FDA. It will be another plus to our PT model,” Dr. Spivak concluded.

Currently, SE Concepts possesses several significant international distribution contracts – spanning the next four years – securing over 500 potential bulk unit sales, or roughly $3 Million per year. However, sales within the global medical community are expected to increase substantially. Companies such as Zen & O (French distributor), which this past October supported SE Concepts by displaying and selling the H2O Body System at an international physiotherapist tradeshow, have increased the company’s penetration into the medical markets abroad. Significant interest is also building rapidly among domestic distributors specializing in the Physical Therapy markets. Obtaining an FDA registration will assist SE Concepts in solidifying the increasing demand for SpaCapsule’s PT model by the health, medical and the wellness communities.


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