Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|10903 New Hampshire Avenue
Silver Spring, MD 20993
SEP 3 2009
VIA FEDERAL EXPRESS
John Hubacher, President
626A Venice Blvd
Venice, CA 90291
Re: Electro-Stimulator, Models 4c. Pro, 6c. Pro, 8c. Pro, 12c. Pro PENS, 6c3i. Pro PENS
Dear Mr. Hubacher:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Electro-Stimulator products (models 4c.Pro, 6c.Pro, 8c.Pro, 12c.Pro PENS, 6c3i.Pro PENS) in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The Office of Compliance in the Center for Devices and Radiological Health (CDRH) reviewed your website, at http://www.pantheonresearch.com. The materials posted on your website indicate that your Electro-Stimulator products (models 4c.Pro, 6c.Pro, 8c.Pro, 12c.Pro PENS, 6c3i.Pro PENS) are "electroacupuncture stimulators" to be used during auricular electroacupuncture, facial electroacupuncture, and body electroacupuncture, for transcutaneous electrical nerve stimulation (TENS); the 12c.Pro PENS and 6c3i.Pro PENS models are also to be used for percutaneous electrical nerve stimulation (PENS). According to the User Manuals posted on your website, your Electro-Stimulator products are intended "to treat patients for many syndromes including pain, addictions, and ... for analgesia during surgery."
These products are medical devices within the meaning of section 201 (h) of the Act, 21 U.S.C. § 321 (h), 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 function of the body. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
A review of our records reveals that you have not obtained marketing approval or clearance before you began offering your products for sale, which is a violation of the law. These devices are adulterated under section 501(1)(I)(B) of the Act, 21 U.S.C. § 351(1)(I)(B), because you do not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(0) of the Act, 21 U.S.C. § 352(0), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by sections 51O(k) of the Act, 21 U.S.C. § 360(k). 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 CFR 807.81 (b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Your devices are also misbranded under section 502(0) of the Act, 21 U.S.C. § 352(0), in that the devices are manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under 21 U.S.C § 360; was not included in a list required by 21 U.S.C. § 3600); or a notice or other information respecting the device was not provided to the FDA as required by 21 U.S.C. § 360(k). Specifically, your firm has not registered your establishment or submitted a device listing to FDA.
The FDA requests that your firm immediately cease the dissemination of promotional materials for these products the same as or similar to those described above. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and/or civil money penalties.
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for these products the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to Jennifer R. Medicus, Acting Branch Chief, Radiology, Anesthesiology, and Neurology Devices Branch, Office of Compliance, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, Maryland 20993, facsimile at (301) 847-8138. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for these products comply with each applicable requirement of the Act and FDA implementing regulations.
Timoty A. Ulatowski
Director Office of Compliance
Center for Devices and Radiological Health