Simulated Environment Concepts, Inc. (SMEV.PK) Announces Intent to Pursue FDA Registration Approval
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…