Products

The FDA requires that certain Class I medical devices, even the simplest ones, cannot be listed, marketed, or advertised until a 510(k) letter of clearance is received stating that it is substantially equivalent to a predicate device and, thus, is in all ways clear for commercial distribution and marketing within the U.S. For reasons of legal and regulatory compliance, therefore, our core patent-pending acupressure product will not be displayed prior to conclusion of its FDA review process.