Classification for HTE USA Products.
Sophisticated natural health
after years of Japanese scientific research.
The FDA currently
classifies the machines in the USA as Regulation
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 Class 1
Therapeutic Electric Massager.
All websites selling health products have
to have a disclaimer.
"This website is for
informational and educational purposes and is not
intended as a substitute for medical advice from a
healthcare provider, and is not to be used to
diagnose, mitigate, treat, cure or prevent any
health problem or disease."
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 and each country has
their own set of rules.
On a closing note, it would be remiss not to address
the letter this website received from the FDA in May
2009. The American Food and Drug Administration were
in disagreement with statements and specific words
written on this International website regarding the
benefits of the four machines (seen here at the
top of this page). Website changes were made
immediately so as to comply with classification, and
all is well.
We sincerely apologized for any naivete on our part
regarding semantics which we had no knowledge of. It
is all very exhausting and confusing, and even more
so working Internationally, because other countries
look at matters completely differently to the USA.
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 health
and wellness, which we take very seriously.
Machine 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 and honesty. It has been 15
years now, and we think we are accomplishing this.
Extensive guidance on natural health and