FDA 483 - Healthtronics, Inc. - May 13, 2022

An FDA inspection of Healthtronics, Inc. in Austin, TX, a medical device manufacturer, revealed significant deficiencies in its design control procedures. The firm failed to establish procedures for design validation and design changes for its TwinTrode electrode. Specifically, Healthtronics could not provide documentation to support claims of increased longevity for the TwinTrode device.