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United States Seizes Unapproved Ozone Generators
Date:1/29/2010

y's inspection revealed significant deviations from the FDA's current good manufacturing practice (GMP) requirements for medical devices, and confirmed that the company has not obtained FDA marketing approval or clearance for these devices. The unapproved status of these devices and the conditions under which they were manufactured cause them to be adulterated and misbranded.

Ozone generators are devices that produce ozone from oxygen. Ozone is present in low levels throughout the earth's atmosphere and has many industrial and consumer applications. It also is an air pollutant that has harmful effects on the respiratory system.

Ozone administration methods suggested by the manufacturer of the AOS-1M Medical Ozone Generator and the AOS-1MD Ozone Generator include blowing ozonized air into the rectal and vaginal areas.

"The seized devices are potentially harmful to public health," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The agency will take action to protect the public from FDA-regulated products that are in violation of the law."

Today's seizure action was jointly conducted by the FDA and the State of California Department of Public Health, Food and Drug Branch as part of ongoing to efforts to ensure that unapproved medical devices that have not been found to be safe and effective do not enter the marketplace.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

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SOURCE U.S. Food and Drug Administration
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