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Legal & Regulatory Issues:
Auri-Stim
Medical, Inc. has attempted to secure the FDA’s approval of
the device for smoking cessation from 1989 until the present date
to no avail.
In November of 1999, the Auri-Stim Medical, Inc. submitted the results
of its clinical trials for smoking cessation and chronic headaches
to the European notifying body. As the result, it obtained a CE-Marking
that allows the Company to market its products in the EU (European
Union) for the indications of Pain Control and Addictions
Therapy.
In addition, the Auri-Stim Medical, Inc. became an ISO-9002:04,
ISO-13485: 96, and ISO-13489:96 certified. These compliances
with the rules and regulations of the various regulatory agencies,
allow the Auri-Stim Medical, Inc. to market it’s products in
the EU, (European Union), and Canada. The Company is in full
compliance and licensed by the Canadian Health Ministry, Medical Devices
Bureau for its products.
NET-1000 and NET-2000 devices were labeled as nerve stimulators
and were classified as Class IIa, low risk medical devices.
This site does not provide medical or any other health care advice
or diagnosis. The site and its services, including the information
above are for informational purposes only and are not a substitute
for professional medical advice, examination or diagnosis. Always
seek the advice of your physician or other qualified health care professionals
before starting any new treatment or making any changes to existing
treatment. Do not delay seeking or disregard medical advice based
on information on this site alone. No health information on this site
should be used to diagnose, treat, or prevent any disease without
the supervision of a medical doctor. The NET-1000 and NET-2000 are
not FDA approved devices. They are made available to the U.S. consumers
without making any medical claims of safety or efficacy. The individual
user is fully responsible for consulting with his/her own physician
for correct diagnosis and causes of the headaches, pms, depression
and symptoms related to smoking. This precaution should be taken in
order to eliminate other possible causes prior to the use of the devices.
The decision to use the device by an individual is a free and voluntary
act. |
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