American F D A Classification
for HTE USA Products.
Sophisticated natural health
from years of Japanese scientific
F D A currently classifies HTE machines in the
USA as medical device, Regulation
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
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."
- Page Last Updated: 12/28/2015
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 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, 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 accomplishment!
Personal Note to Readers:
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
over a decade ago, demanding articles be
rewritten, words eliminated, and documentation
removed so as to comply with their regulations, to
limit information so as to remain within certain
boundaries. We of course complied.
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 19 years now,
and we believe we are accomplishing this.