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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Chi Machine International

   

Department of Health and Human Services logoDepartment 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:

1. Sun Ancon Chi Machine:

• "Oxygen therapy results:

o Aids in the prevention of Cancer - Growths - Tumors[.]
o Aids in the prevention of heart attack and heart disease.
o Boosts the capacity of bone marrow to produce red blood cells.
o Treats disc problems and lower back pain.
o Expedites wound healing.
o Combats the AIDS virus[.]
o Dilates the esophagus thus relieving respiration problems, choking or coughing."

• "Excellent for oxygenation, detoxification, spinal alignment, ... cancer, ... lymphoedema, ... "
• "AIDS, herpes, hepatitis, Epstein Barr, cytomegalovirus and other lipid envelope virus are readily destroyed by hyper-oxygenating patients blood with ozone."

2. Far Infrared Hothouse Sauna Dome:

• "Infrared Sauna Hothouse Dome Health Benefits:

o Excellent treatment for chronic diseases, especially Cancer - Prostate Cancer Ovarian, Breast, Colon[.] {(emphasis in original)]
o Excellent for alleviation of rheumatism, arthritis, gout, and reducing the density of uric acid.
o Excellent for clearing breathing problems such as asthma, sinusitis, allergies and bronchitis.
o Very good for relieving paralysis, sciatica, insomnia, neuralgia, abnormal nerve functions, high blood pressure and chilblains.
o Excellent for reducing swelling, inflammation and associated pain.
o Excellent for serious detoxification.
o Stimulates blood circulation - Very effective for chronic nephritis patients, reducing blood pressure and improving urination. Effectively improves and can eliminate piles and hemorrhoids.
o Promotes the killing of many pathogenic (disease causing) bacteria, viruses, fungi and parasites.

3. Electro Reflex Energizer (ERE):

• "Excellent for blood circulation, ..., sciatic pain, ..., arthritis, ..., neuropathy, ... Known to kill tapeworms and parasites."
• Relieves carpal tunnel syndrome and muscle spasms. Excellent for neuropathy. Expediates healing of bruises."
• " ... relief from painful carpal tunnel syndrome and in many cases, a complete clearing of pain."
• "Promotes the break down of fat cells and aids in detox via the electro pads."

4. E-Power Machine:

• "Excellent for ..., accelerated healing. Activates cells, increases blood circulation, ..., increases the ATP enzyme responsible for aging."
• "E-Power machine targets eight body systems:

o The Circulatory System
o The Nervous System
o The Digestive System
o The Urinary System
o The Immune System
o The Skeletal System
o Weight Loss
o The Skin"

• "Oxygenation, Blood Pressure, Detox, pH Balance, Accelerated Healing, Mental Focus - Improvement of blood circulation due to vasodilation allowing:

o Can lower blood pressure
o Can increase detoxification
o Accelerate healing of wounds"

• "Bones - Triggers the Spleen and Bone Marrow to Increase Calcium ..."
• "Healing - Shortens recovery and repair time for athletes and personal physical disabilities by:

o Strengthening muscles, bones, tendons, and ligaments
o Inflammation reduced
o Great for rheumatism, arthritis, bruises, fractures, paralysis, muscle and nerve tension
o Risk of injury and regeneration of injured cells reduced."

• "Pain - Relief by:

o Interrupting transmission of pain stimulus to the brain
o Muscle tension, leg cramps and spasm relief."

• "Your Weight - Improves the Function of the Stomach and Intestines through:

o Metabolism increase
o Weight loss and building of muscle mass increase
o Regulation of plexus myenterium by increasing digestion activity."

• "Your beauty - Increases Collagen ..."

5. SOQI Bed (Far Infrared Hothouse and Chi Machine together):

• "Excellent for accelerated healing, ..., blood circulation, oxygenation, spinal alignment, lung and breathing problems, skin problems, ..., tissue regeneration, ..., cancer therapy."
• "Skin problems such as scars, burns, acne, rashes and wrinkles will fade and heal via the far infrared therapy which stimulates tissue regeneration."
• "Excellent for cancer therapy...Outstanding for prostate cancer."
• "Many people suffering from terminal illness such as cancer or any severe total body dysfunction also opt for this complete treatment. There are no side effects involved, no pain, no needles and no medication. Simple, natural, safe, non-toxic, therapeutic, alternative healing, for health, fitness and wellness."
• "Far Infrared is excellent for the skin - acne, wrinkles, rashes, bums and scars. Far Infrared regenerates tissue growth."

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