FDA Classification
HTE
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FDA Classification for HTE USA Products
and Required Disclaimer.


Four healing machines

The FDA in the USA does not recognize the Sun Ancon Chi Machine, the FIR Hothouse, the Electro Reflex Energizer or the E-Power as medical device because to obtain such classification from the FDA would be outrageously expensive (the FDA require an upfront fee, plus expensive clinical trials conducted in the USA) and takes a very long time to obtain.

It would actually be redundant to obtain such classification in the USA, because this has already been bestowed by three other countries:

Clinical Trials
were conducted on the Sun Ancon Chi Machine at Flinders University in Australia, June 2000, by Prof. Neil Piller.

Medical Device Classification was granted by Japan in 1993, Australia in 2001 and Canada in 2004.


The FDA has chosen to classify the machines in the USA as
Regulation Class 1:


The Chi Machine is Regulated as a Class 1 Therapeutic Massager - FDA Listing
The Far Infrared Hothouse is Regulated as a Class 1 Powered Heating Unit - FDA Listing
The Electro Reflex Energizer is Regulated as a Class 1 Therapeutic Electric Massager -
FDA Class
The E-Power
is Regulated as a Class 1 - FDA Class

FYI: The FDA website presents a medical device definition page, that clearly applies to the four machines above but they are not eligible unless FDA protocol is applied. It is of course frustrating that tongue depressors and bedpans are classified as medical device, but not the four machines above, despite having medical device classification status outside the USA, and being used worldwide by medical professionals, including those within the USA.

FDA Medical Classification: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm 




FDA Required Disclaimer:
Statements on this website have not been evaluated by the FDA - the Food and Drug Administration.
HTE products are not intended to diagnose, cure or prevent any disease. NO product can seriously claim to do so, because too many factors are involved for each and every individual.

The information provided on this website is for informational purposes. Information is not intended as a substitute for advice from your personal physician or other health care professional that you trust, and should not be construed as individual medical advice.

If you are under a doctors' care, please consult with her/him prior to use of these products. If a condition persists, please contact your physician for advice.

Any testimonials on this website are from individual cases. and cannot guarantee in any way, shape or form, that you will get identical results.




Classification outside of USA:
The Sun Ancon Chi Machine, the Far Infrared Hothouse, the ERE and the E-Power are all recognized, classified, approved and certified as MEDICAL DEVICE in Canada, Australia and Japan.

It must be noted that:
a) Australian and Canadian health regulations are extraordinarily strict and such classification is not easily or lightly obtained.

b) Japan ranks as having the highest health level in the world, whereas the US ranks among the lowest. All four machines were created by Japanese scientists, with exclusive distribution rights given to HTE.

HTE, is the international company that has the exclusive rights to manufacture, import and sell these machines in the USA, since U.S. establishment in 1993 - company actually initially established in 1990 in Taiwan.

HTE, the company and manufacturer of these four machines, has never had a consumer lawsuit or consumer injury during the past 24 years plus of doing business worldwide - quite an accomplishment!



Geek
International Distributor.
Personal Note:
As a consumer, just like the reader of this page, it does not make sense that things can be classified differently in different locations and different countries - either it is, or it isn't so to speak - but matters are not always so clear cut.

Everyday examples:
1)  In the USA, why can a masseuse be certified in one city, district or state, but not certified in another just miles away?
2)  Why is it that scientific research and information proving that certain products are either truly harmful or truly healing, banned from being revealed or given to the public?
3)  Why is it that certain products and services can be sold and offered in one country, but banned in another?
4)  Machines, such as those above, are recognized as medical device in certain countries, but refuted as such by a country a few steps away across an invisible border (Canada and USA)?

Such are the laws and regulations of government and corporations ruled by politics and semantics, often defined by money and religion, over which the average consumer or merchant has minimal, to restricted, to no jurisdiction.

The good news is that there is barely a corner on earth that International marketing cannot reach, and business is now truly global thus enabling the consumer to be able to research and obtain any product or service they desire.


Warning Letter:
On a closing note, it would be remiss not to address the warning letter this website received from the FDA in May 2009. The FDA were in disagreement with statements written in this website regarding the ability and benefits of the four machines (seen here at the top of this page). As the machines are not classified as medical device in the USA, specific statements and specific words, are forbidden by the FDA and were in violation of their rules.

Website changes were made immediately so as to comply with the current FDA classification, and all is well. We sincerely apologized for any naivete on our part regarding FDA rules, regulations and semantics which we had no knowledge of.

Our intentions are for the highest good of all. Honesty is truly extremely important to us.
We stand by our vow to never intentionally mislead or misrepresent modalities and device used for healing and wellness, which we take very seriously.

Chi Machine International's Mission is to simply make a difference and reach out and help individuals worldwide to the very best of our ability with integrity, sincerity, compassion and honesty.



FDA Classification - Disclaimer
2002-2014 Chi Machine International Independent HTE Distributor - www.chimachine4u.com

Chi Machine
          International