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

HTE mach

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

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


The Electro Reflex Energizer is Regulated as a Class 1 Therapeutic Electric Massager
.
The E-Power
is Regulated as Class 1 Therapeutic Electric Massager.

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



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, do not allow any testimonials that reference specific illnesses or disease without scientific clinical trials.

"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."

- www.fda.gov/AboutFDA/Transparency/Basics/ucm194438.htm
- Page Last Updated: 12/28/2015



Classification outside of USA:
HTE's four 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 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. 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 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. It is all very confusing and constantly changing 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 fence!


Chi 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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American Food and Drug Administration Classification - HTE USA Machines
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