Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
  9200 Corporate Boulevard
Rockville, Maryland 20850

WARNING LETTER

May 21 2009

VIA FEDERAL EXPRESS

Ms. Tracy Courtney
Chi Machine 4 U
4222 Ethel Avenue
Studio City, CA 91604

Dear Ms. Courtney:

The Food and Drug Administration (FDA) has learned that your Firm is marketing the Sun Ancon Chi Machine, Far Infrared Hothouse Sauna Dome, Electro Reflex Energizer, E-Power Machine, and SOQI Bed in the United States (U.S.) without marketing clearance or 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), the Sun Ancon Chi Machine, Far Infrared Hothouse Sauna Dome, Electro Reflex Energizer, the E-Power Machine, and SOQI Bed 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 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 medical 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.

The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your Web site, http://www.chimachine4u.com. Specifically, your Web site contains statements that represent or suggest that your devices, as follows, are adequate and effective to treat the following intended uses:

A review of our records reveals that you have not obtained marketing approval or clearance before you began offering your devices for sale, which is a violation of the law. In addition, a review of our records and your Web site indicates that your Studio City, CA, and Plainview, NY, establishments are the initial importer and distributor, respectively, and that your firm's Hefei, China, establishment is the manufacturer.

The Sun Ancon Chi Machine, Far Infrared Hothouse Sauna Dome, Electro Reflex Energizer, E-Power Machine, and SOQI Bed devices 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), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C.360j(g). Your 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 device into commercial distribution, as required by sections 510(k) of the Act, 21 U.S.C. 360(k). For devices 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/deviceadvice/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 Chi Machine 4 U and firms doing business as Chi Machine 4 U immediately cease the dissemination of promotional materials for Sun Ancon Chi Machine, Far Infrared Hothouse Sauna Dome, Electro Reflex Energizer, E-Power Machine, and SOQI Bed that are the same or similar to those described above in the Website: www.chimachine4u.com. You should take prompt action to correct the violations. Given the serious nature of the violations of the Act, Sun Ancon Chi Machine, Far Infrared Hothouse Sauna Dome, Electro Reflex Energizer, E-Power Machine, and SOQI Bed manufactured by your firm are subject to refusal of admission under section 801 (a) of the Act, 21 U.S.C. 381(a), in that they appear to be adulterated and misbranded. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your response is adequate.

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 Sun Ancon Chi Machine, Far Infrared Hothouse Sauna Dome, Electro Reflex Energizer, E-Power Machine, and SOQI Bed devices 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 Ms. Xuan T. Vo at the Food and Drug Administration, 2094 Gaither Road, Rockville, Maryland 20850, facsimile at (240) 276-0129. 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 devices comply with each applicable requirement of the Act and FDA implementing regulations.

Sincerely,

/S/

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health

cc: Barbara Moynier
Unit Chief, Medical Devices
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue, MS 7602
P.O. Box 997435
Sacramento, California 95899-7435

This page was posted on January 31, 2010.

Links to Recommended Companies