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Plexus International

This article was originally published in The Gray Sheet

Executive Summary

Receives May 4 warning letter from FDA for promotional claims of the company's MyoPlex 6000 muscle stimulator. Statements that the Myo-Plex provides "'[relief] of pain; removal of edema; muscle relaxation; rehabilitation of injured tissues'"; and other claims, "extend beyond the original intended use of a muscle stimulator," the agency contends. Plexus also is cited for failing to submit the necessary premarket notification for the device. The Houston, Texas-based company is the subject of an investigation by the ABC television show 20/20
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