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