American FDA Classification
for HTE USA Products.
Sophisticated natural health machines created
from years of Japanese scientific
The American FDA currently
classifies HTE machines in the USA as medical
device, Regulation Class 1:
FDA Medical Classification Page:
Food and Drug Administration Protocols:
All websites selling health products have to post a
"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 medical diagnosis or disease
in specific reference to a product sold in the USA
without scientific clinical trials.
Devices are assigned one of three
classifications within the USA:
"FDA classifies medical devices
based on the risks associated with the device.
Devices are classified into one of three categories
- Class I, Class II, and Class III.
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 USA:
HTE's four main health
machines - The Sun Ancon Chi Machine, the Far Infrared
Dome, the Electro Reflex Energizer and the E-Power
Machine - are all recognized, classified and certified
as medical device in Canada, Australia and
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 well below. HTE machines
were created by Japanese scientists, with exclusive
distribution rights given to HTE.
c) 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 in countries across Asia,
Australia and North America.
d) HTE has not
had a consumer lawsuit or consumer injury during the
past 28 years plus of
doing business worldwide - quite an accomplishment!
Personal Note to Readers:
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, rules and
regulations. It is all very confusing, especially 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.
The F D A found fault with us several
years ago, demanding articles be
rewritten, words eliminated, and documentation
removed so as to comply with their
regulations, to limit public information, to
remain within certain boundaries. We of course
Clarity, transparency and
honesty is extremely important to us, on both 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 17 years now, and
we think we are accomplishing this. Namaste.