Inspections, Compliance, Enforcement, and Criminal Investigations
Ocean Hyperbaric Center 9/11/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|10903 New Hampshire Avenue
Silver Spring, MD 20993
SEP 11 2009
VIA FEDERAL EXPRESS
Ocean Hyperbaric Neurologic Center
4001 Ocean Drive
Lauderdale by the Sea, FL 33308
Re: Sechrist Horizontal Hyperbaric Chamber
Vickers "Clam Shell" Hyperbaric Chamber
Dear Ms. Neubauer:
The Food and Drug Administration (FDA) has learned that your facility is promoting the Sechrist Horizontal Hyperbaric Chamber and Vickers "Clam Shell" Hyperbaric Chamber in the United States, for uses that have not received marketing approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of 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 function of the body. The Office of Compliance in the Center for Devices and Radiological Health (CDRH) reviewed the promotional claims on your website, http://www.oceanhbo.com, for the Sechrist Horizontal Hyperbaric Chamber and Vickers "Clam Shell" Hyperbaric Chamber products. A review of our records reveals that you have not obtained marketing approval for the uses promoted on your website, which is a violation of the law.
Specifically, your website promotes and advertises use of these devices for treatment of the following neurological conditions, which include but are not limited to:
o Multiple Sclerosis;
o Lyme Disease;
o Cerebral Palsy;
o Reflex Sympathetic Dystrophy;
o Carbon monoxide intoxication;
o Traumatic brain injury; and
o Anoxic ischemic encephalopathy.
The Sechrist Horizontal Hyperbaric Chamber and Vickers "Clam Shell" Hyperbaric Chamber products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(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). Moreover, it is a prohibited act under section 301(k) of the Act, 21 U.S.C. § 331(k ), to do any act with respect to a device, if such act is done while the device is held for sale1 after shipment in interstate commerce, and results in the device being adulterated or misbranded. The kind of information you need to submit in order to obtain approval 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.
The Office of Compliance requests that your firm immediately cease making any claims for the Sechrist Horizontal Hyperbaric Chamber and Vickers "Clam Shell" Hyperbaric Chamber that are identical or similar to those described above. You should take prompt action to correct the violations addressed in this letter. 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 the Sechrist Horizontal Hyperbaric Chamber and Vickers "Clam Shell" Hyperbaric Chamber that are 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 the Sechrist Horizontal Hyperbaric Chamber and Vickers "Clam Shell" Hyperbaric Chamber comply each applicable requirement of the Act and FDA implementing regulations.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and Radiological Health