Classification for HTE USA Products
and Required Disclaimer.
The American FDA
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 numerous expensive clinical trials
conducted in the USA), and takes a very long time to
It would actually be redundant to obtain such
classification in the USA, because medical
classification has already been bestowed by three
other countries, and clinical trials already
conducted in Australia.
were conducted on the Sun Ancon Chi
Machine at Flinders University in Australia, June
2000, by Prof. Neil
Classification was granted
by Japan in 1993, Australia in
2001 and Canada in 2004.
The FDA classifies the machines in the USA as
Regulation Class 1:
The Chi Machine is
Regulated as a Class 1 Therapeutic Massager.
The Far Infrared
Hothouse is Regulated as a Class 1 Powered Heating
The Electro Reflex
Energizer is Regulated as a Class 1 Therapeutic
The E-Power is Regulated as a Class
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
Statements on this
website have not been evaluated by the American FDA
(the Food and Drug Administration). HTE products are not
intended to diagnose, cure or prevent any disease (actually
NO product can seriously claim to do so, because
too many factors are involved for each and every
individual and no two are identical).
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
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
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
It must be noted
a) Australian and
Canadian health regulations are extraordinarily
strict and such classification is not easily
or lightly obtained.
b) Japan ranks as
having one of the the highest health levels in the
world, whereas the U.S. ranks far below. All four
machines were created by Japanese scientists, with
exclusive distribution rights given to HTE.
HTE (Hsin Ten
Enterprise) is the international company that has
the exclusive rights to manufacture, import and sell
these machines in the USA since establishment in
1993. HTE world head office was established in
HTE, the company
and manufacturer of these four machines, has never had a consumer
lawsuit or consumer injury during the past 25 years
plus of doing business worldwide - quite an
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 such matters
are not always so clear cut.
the USA, why can a masseuse be certified in one
city, district or state, but not certified in
another just miles away across an invisible state
Why is it that scientific research and information
proving that certain products are either truly
harmful or truly healing, are banned from being
revealed or given to the public?
Why is it that certain products and services can be
sold and offered in one country, but banned in
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 vs 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
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, even if denied in the country they
On a closing note, it would be remiss not to address
the warning letter this website received from the
FDA in May 2009. The American FDA were in
disagreement with statements written in this
international 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 prohibited 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
and transparency is extremely important to us.
stand by our vow to never intentionally mislead or
misrepresent modalities and device used for healing
and wellness, which we take very seriously.
International's Mission is to simply make
a difference and reach out and help individuals
worldwide, to help humanity to the very best of
our ability with integrity, sincerity, compassion
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