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DETERMINATION OF DEVICE SAFETY
Since the magnetic energy that is produced by this device is in the pico-Tesla range, the magnetic energy that is delivered to the body is a fraction of the magnetic energy produced by the earth on a constant basis. There are no other hazards identified with this device. The device is not intended as an implant, it is not purported or represented to be for a use in supporting or sustaining life, and it is not for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health.
For more information, please refer to the ‘Non-Significant Risk Determination’ report contained in Appendix A of this clinical trial protocol.
IRB DETERMINATION OF NON-SIGNIFICANT RISK (NSR) STATUS
Independent Review Consulting, Inc.‘s Institutional Review Board determined the Resonator™ device to be a non-significant risk (NSR) device when applied in the following five studies:
- IRC # 07021, NSR#DAM-001: Jacobson Resonator™: Efficacy of the Application of Magnetic Fields to the Treatment of Parkinson‘s Disease Pilot Study Protocol, APPLIED MAGNETICS, LLC. Version 1.6, February 20, 2007
- IRC# 07102-01Jacobson Resonator™: A double-blind, sham-stimulation controlled study of the application of magnetic fields using the Jacobson Resonator™ for the treatment of Parkinson’s Disease: phase two pilot study protocol. Version 2.5, Oct 2007.
- IRC# 06052-01.An open label extension study for subjects previously treated in either pilot I or pilot II studies of the application of magnetic fields using the Resonator™ device for the treatment of Parkinson's disease: Extension pilot study protocol, Version 4.0, March 14, 2008.
- IRC#09026, NSR#DAM-005: A randomized, double-blind, sham-stimulation controlled study of the application of magnetic fields using the Resonator device for the treatment of Parkinson's disease clinical trial protocol. Version 4.13, July 1, 2010.
- IRC#09109, NSR#DAM-004: A randomized, double-blind, placebo-controlled study of the application of magnetic fields using the Resonator in adjunctive management of Type II Diabetes Mellitus. Version 1.2, April 6, 2010
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