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Legal & Regulatory Issues

Neural stimulation for smoking cessation and pain relief

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, Auri-Stim Medical, Inc. submitted the results of its clinical trials for smoking cessation and pain relief 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. This has not been updated due to the cost factor.

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. This has not been updated due to the cost factor.

NET-1000 and NET-2000 devices were labeled as nerve stimulators and were classified as Class II and 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 is not an FDA approved device. It is 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.