*
FDA
Classification for HTE USA Products
and Required Disclaimer.
The FDA in the
USA does
not recognize the Chi Machine, the Hothouse, the
Electro Reflex
Energizer or the E-Power as medical device because
to obtain such
classification from the FDA would be extraordinarily
expensive (the FDA require a large fee plus American
clinical trials)) and takes a very long time to
obtain.
NOTE:
Clinical trials were conducted on the Chi Machine in
Australia, June 2000, and medical device
classification granted by Japan in 1993, Australia
in 2001 and Canada in 2004.
However, the FDA has classified 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
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 - 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 do not
guarantee in any way, shape or form that you will
get the same 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 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 20 years of
doing business worldwide - quite an
accomplishment!
International Distributor.
As a consumer, just like the reader of this page, is
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 uncertified 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 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 across an invisible
border?
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.
Chi Machine International's mission is
simply to make a difference and
reach out and help individuals worldwide to the very
best of our
ability with integrity, sincerity, compassion and
honesty.
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