FDA Classification for HTE USA Products.
Sophisticated natural health
from years of Japanese scientific
The American FDA currently
classifies HTE machines in the USA as Regulation
Food and Drug
Administration required disclaimer and why:
All websites selling health products have
to have a general 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."
The FDA do not allow mention of any illness or
disease in specific reference to a product sold in
the USA without clinical trials that have been
conducted within the USA. The FDA therefore, also
do not allow any testimonials that reference
specific illnesses or disease without scientific
medical devices based on the risks associated with
the device. Devices are classified into one of
three categories - Class I, Class II, and Class
Class I devices are deemed to be low risk
and are therefore subject to the least regulatory
controls. For example, dental floss is classified
as Class I device.
Class II devices are higher risk devices
than Class I and require greater regulatory
controls to provide reasonable assurance of the
device’s safety and effectiveness. For example,
condoms are classified as Class II devices.
Class III devices are generally the highest
risk devices and are therefore subject to the
highest level of regulatory control. Class III
devices must typically be approved by FDA before
they are marketed. For example, replacement heart
valves are classified as Class III devices."
- Page Last Updated: 12/28/2015
Classification outside of
main health machines - The Sun Ancon Chi Machine,
the Far Infrared Hothouse Dome, the Electro Reflex
Energizer and the E-Power Machine - are all
recognized, classified and certified as medical
device in Canada,
Australia and Japan.
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. HTE
machines were created by Japanese scientists, with
exclusive distribution rights given to HTE.
HTE (Hsin Ten
Enterprise) is the international company that
manufactures the machines and was first established
in the USA in 1993. HTE world-quarters head office
was established in Taiwan 1990, with individual head
offices then set up for countries across Asia,
Australia and North America.
HTE 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 as each country has
their own set of politics and rules. It is all very
confusing as regulations constantly change within
the USA from one year to the next, but we strive to
understand and follow protocol to the very best of
our knowledge and understanding.
Clarity and transparency is
extremely important to us on all sides of every
Machine International's Mission
is to simply make a difference and reach out and
help individuals worldwide, to help humanity with
integrity, sincerity, compassion and honesty. It
has been 15 years now, and we think we are
accomplishing this. Namaste.
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