FDA WARNING_LETTER - Pelvic Therapies, Inc

On October 17, 2017, the FDA issued a Warning Letter to Pelvic Therapies, Inc. for distributing and promoting the Essential TheraWand, Premium TheraWand, PelviWand-LA, and PelviWand-V products without marketing clearance or approval. The FDA determined these products are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The devices are adulterated under section 501(f)(1)(B) of the Act because Pelvic Therapies, Inc. lacks an approved premarket approval (PMA) or investigational device exemption (IDE) application. They are also misbranded under section 502(o) of the Act for failing to notify the FDA of intent to introduce the devices into commercial distribution, as required by section 510(k).

The Warning Letter cites specific unapproved intended uses promoted on the company's websites and Amazon, including treatment for pelvic floor muscle dysfunction, vaginismus, IBS, chronic constipation, sexual and rectal pain, endometriosis, and urological disorders. The FDA previously requested clearance information in October 2016, to which the firm provided an initial, but no further, response. Additionally, a "for-cause" inspection attempt in December 2016 was refused.

Furthermore, Pelvic Therapies, Inc. has not fulfilled annual establishment registration