FDA Warns Pelvic Therapies to Cease Unapproved Activities

The FDA has requested that Pelvic Therapies in Carlsbad, California “immediately cease activities” that have resulted in the medical devices manufactured at its facility being adulterated and misbranded.

The agency issued a warning letter after agency officials concluded, in a review of marketing claims and materials available online, that its Essential TheraWand, Premium TheraWand, PelviWand-LA and PelviWand-V were introduced for commercial distribution without receiving the required approvals or clearances from the FDA.

The firm promoted several intended uses for the devices, such as for endometriosis and Crohn’s diseases, that have not been evaluated by the FDA.