FDA WARNING_LETTER - Savec Health Systems

On December 10, 2008, the FDA issued a Warning Letter to Admare Jinga, Savec Health Systems, regarding the Omnivir device, which is being marketed in the U.S. without marketing clearance or approval. The FDA's Office of Compliance reviewed the firm's website, www.savechealthsystems.com, and determined the Omnivir is a device under Section 201(h) of the Act.

The Omnivir device is adulterated under section 501(f)(1)(B) of the Act because there is no approved premarket approval (PMA) application or investigational device exemption (IDE). It is also misbranded under section 502(o) for failure to notify the agency of intent to introduce the device into commercial distribution, as required by section 510(k). Furthermore, the device is misbranded under section 502(a) because its labeling, including the website and Patient Information Leaflet, makes unproven claims such as "[f]ight HIV/AIDS and related opportunistic infections" and "[protect] the immune system," which are false or misleading.

Additionally, the Omnivir device is misbranded under section 502(j) as it is dangerous to health when used as prescribed in its labeling. Specifically, instructions for rectal insertion and administration of medicine/oxygen/ozone gas mixture do not adequately describe measures to prevent the risk