American F D A Classification
for HTE USA Products.
Sophisticated natural health
from years of Japanese scientific
The American F D A currently
classifies HTE machines in the USA as medical
device, Regulation Class 1:
F D A Medical Classification Page:
Food and Drug
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."
2) The F D A do not allow mention of any
medical diagnosis or disease in specific reference
to a product sold in the USA without scientific
clinical trials and fees.
3) Devices are
assigned one of three classifications within the
"F D A
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 F D A before
they are marketed. For example, replacement heart
valves are classified as Class III devices."
Classification outside of USA:
four main health machines - The Sun Ancon Chi
Machine, the FIR Dome, the Electro Reflex Energizer
and the E-Power Machine - are recognized, classified
and certified as medical device in Canada, Australia and
a) Australian and Canadian health regulations
are extraordinarily strict and such
classification was 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, North America and Australia.
HTE has not had a consumer lawsuit or consumer
injury during the past 30 years plus of doing
business worldwide - a distinguished
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
which generate billions of dollars in pharmaceutical
It is all very confusing, especially as regulations
constantly change within the USA from one year to
the next, but we strive to follow protocol to the
very best of our knowledge and understanding.
The F D A found fault with us
well over a decade ago, demanding articles be
rewritten, specific words eliminated, and
scientific documentation be removed so as to
comply with their regulations, to limit public
information so as to remain within their
boundaries. We of course complied and continue to
Clarity, transparency and
honesty is extremely important to us, especially
regarding health, on both
sides of every fence!
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 22 years now, and we believe we
are accomplishing this.