Simulated Environment Concepts, the manufacturer and developer of medical, aesthetic and wellness equipment, announced this morning 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,” comment 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.
The company has secured multiple significant international distribution contracts – spanning the next four years – securing over 500 potential bulk unit sales, or roughly $3 Million per year. Furthermore, it is anticipated sales within the global medical community will 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 global medical markets. Significant interest is also building in the United States. By obtaining an FDA registration, SE Concepts aims to solidify the increasing demand for its PT model by the health, medical and the wellness communities.
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