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Warnings

PainDx is sole USA source and manufacturer of the Axon-II device. The unique technology embodied in this device and method are covered by US and foreign patents and patents pending. The unique technology of the Axon-II received FDA marketing clearance December 1, 1997.

CAUTION
Federal law restricts this device to sale by or use on or by the order of a physician, or a practitioner who is licensed in the state in which he practices to use or order the use of this device.

ADVERSE EFFECTS
No adverse effects have been found to be associated with the diagnostic application of the Axon-II.

CONTRAINDICATIONS
None.

INDICATIONS AND USAGE
The Axon-II is a diagnostic device that allows the quantitative detection of various sensory neurological impairments caused by various pathological conditions or toxic substance exposures. The subject population for whom this device can be used for diagnostic purposes includes any individual capable of communicating the perception of cutaneous sensation. The Axon-II diagnostic examination may be conducted as part of the neurological examination or for screening to detect peripheral neuropathies.

WARNING
Patients cannot feel pain generators, since the primary lesion is hypoesthetic (numb). Patients are most often complaining of referred pain, not the primary lesion. This new technology can detect the earliest changes in the most vulnerable nerves - the sensory nerves, thereby allowing accurate intervention before degeneration has even begun.

LEGAL PATENTS
The electrode system and methods are protected by US patents and copyrights. The EMG used in the Axon-II System is separately manufactured and covered by separate patents and FDA marketing clearances.




Sole Distributor and Manufacturer:  PainDx, Inc. - Axon-IITM NCSs SystemTM
PHONE: 1-800-766-0884  -  E-MAIL: email@nervepathology.com

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This website is not for general public use. It is meant for physician reference only.
Nothing presented is meant to represent or imply use other than the FDA Indication and usage.

FDA Indications and Usage: The Axon-IITM NCSs is a diagnostic device that allows the quantitative detection of various sensory neurological impairments caused by various pathological conditions or toxic substance exposures. The subject population for whom this device can be used for diagnostic purposes includes any individual capable of communicating the perception of cutaneous sensation (with the potentiometer, which has a separate FDA clearance, the test is not dependent on the subject reporting perception of the cutaneous sensation, since the action potential of the nerve firing is detectable by the potentiometer). The Axon-IITM NCSs diagnostic examination may be conducted as part the neurological examination or for screening to detect peripheral neuropathies.

Legal Notice

DOCUMENTS

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TRADEMARK NOTICE
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Copyright © 2010 PainDx, Inc. - Axon-IITM NCSs SystemTM  All Rights Reserved.