Availability:

In
the U.S. only, the NET-1000 device will be made available to the
consumers without making any medical claims of Safety or Efficacy.
The NET-1000 and NET-2000 are not the FDA approved devices.
For other Countries, in November of 1999, Auri-Stim Medical Inc.
obtained a CE-Marking and approval from the EU (European Union),
and the Canadian Ministry of Health for its products. It became
an ISO-9002:04, ISO-13485: 96, ISO-13488: 96 certified that allows
the company to market the devices in the respective Countries. The
NET-1000, NET-2000 devices were labeled as nerve stimulators and
classified in Class IIa, low risk medical devices with the intended
use for Pain Control and Addictions Therapy.
In the past ten years, the Company had secured approval for the
NET-1 device from the Ministries of Health of the following Countries:
the Netherlands, the United Kingdom, Switzerland, and Australia.
Permissions to export the device to the respective countries were
also secured from the FDA. The Company is licensed to market its
products in Canada by the Canadian Health ministry, Medical Devices
Bureau. In the U.S. the FDA's approval of the NET-1000 device for
smoking cessation at best is uncertain.
For further information regarding the availability of the NET-Devices
in Canada, and Europe please contact
us.
This portfolio is available for Licensing, Joint Venture and
Start-Up Investment.
This Technology is available for Licensing and Commercial Partnership.
U.S. Patents are pending.
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