FDA
                  classification
HTE
-
*
FDA Classification for HTE USA Products.

Four healing machines

Sophisticated natural health machines invented
after years of Japanese scientific research.

 
The FDA currently classifies the machines in the USA as Regulation Class 1:


The Chi Machine is Regulated as a Class 1 Therapeutic Massager.
The Far Infrared Hothouse is Regulated as a Class 1 Powered Heating Unit.
The Electro Reflex Energizer is Regulated as a Class 1 Therapeutic Electric Massager
.
The E-Power
is Regulated as Class 1 Therapeutic Electric Massager.

fcCMFcHH



FDA Medical Classification Page:
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm



FDA Required Disclaimer:
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 USA:
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 Japan.

It must be noted that:
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 Taiwan, 1990.

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 accomplishment!



Geek
International Distributor.
Personal Note:
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.

Warning Letter:
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.
We stand by our vow to never intentionally mislead or misrepresent modalities and device used for health and wellness, which we take very seriously.

Chi 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. Namaste.


tel
CONTACT US
24hr Hotline and Email.


chi
HOME
Extensive guidance on natural health and nutrition.

FDA Classification
2002-2016 Chi Machine International Independent HTE Distributor - Copyright - Privacy Policy

Chi Machine
          International