Pelvic Therapies, Inc FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

The United States Food and Drug Administration (FDA) has learned that your firm, Pelvic Therapies, Inc., located in Carlsbad, California, distributes and promotes the Essential TheraWand, Premium TheraWand, PelviWand-LA and PelviWand-V products in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any function of the body.

FDA has reviewed the marketing claims and materials shown on your websites; www.thera-wand.com, www.pelvictherapies.com, and Amazon’s website, www.amazon.com/s/ref=nb_sb_noss_1?url=search-alias%3Daps&field-keywords=therawand, and determined that the devices, the Essential TheraWand, Premium TheraWand, PelviWand-LA and PelviWand-V, are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). These devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm di

Potential Health Risks

Office of Medical Device and Radiological Health OperationsDivision 3 West19701 Fairchild RoadIrvine, CA 92612

On October 20, 2016, the Center for Devices and Radiological Health mailed your firm an FDA correspondence requesting your firm to provide the FDA the clearance number for the Essential TheraWand and Premium TheraWand or, if you do not believe that you are required to obtain FDA clearance for the Essential TheraWand and Premium TheraWand, to please provide us with the basis for that determination. While your firm initially responded to our letter, your firm has not responded to further attempts to contact you. Additionally, on December 9, 2016, Los Angeles District Office attempted a “for-cause” inspection of your firm and was refused entry.

US Food and Drug AdministrationDivision 3/WestOffice of Medical Device and Radiological Health Operations19701 FairchildIrvine, CA 92612-2506

Regulatory Context

For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency, 21 C.F.R. 807.81(b). The kind of information you need to submit to obtain approval or clearance for your device is described on the Internet at:http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm#step2. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

Also, under section 510 of the Act, 21 U.S.C. § 360, manufacturers of medical devices are required to register with the FDA annually. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2017.

Therefore, all your firm's devices are misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(o), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360, and were not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j).