The US FDA has filed a seizure and forfeiture complaint for unapproved medical devices called, “Dr Ho’s Double Massage” and “Dr Ho’s Muscle Massage.”
But, in all seriousness, this is serious:
The devices, components, and accessories, are adulterated under the Federal Food, Drug, and Cosmetic Act because they are unapproved class III medical devices and they do not meet mandatory performance standards. In addition, the devices are labeled for use to treat serious medical conditions, including diabetic neuropathy, fibromyalgia, arthritis, and migraine headaches. Since these devices have not been approved by FDA, the safety parameters associated with their use and the efficacy of the devices for use to treat diseases have not been determined. These devices are misbranded because their labeling lacks adequate directions for intended use, they are not labeled prescription use only, and they are not being used by consumers by order of a licensed practitioner. They are further misbranded because they were manufactured at an unregistered facility.
Protecting the public against products illegally marketed without FDA approval is an important part of the mission of our agency,” stated FDA Acting Commissioner von Eschenbach. “The unapproved claims on products such as these often lead patients to forego proven therapies, which can cause serious health consequences.”