The Magnesphere™ is classified under the U.S. Food and Drug Administration (FDA) regulation 21 CFR 890.5660. Under this product regulation the Magnesphere™ device is classified as a Class I medical device, exempt from 510(k) Premarket Submission. The FDA Product Code for the Magnesphere™ is ISA by the Physical Medicine Review Panel. The Magnesphere™ FDA product listing number is D134631." See the Certificate of Compliance.
There have not been any serious medical adverse events resulting from exposure to the Magnesphere™ device (or its predecessor model, the Resonator). However, in other studies, magnetic stimulation from stronger fields has been shown to increase the risk of seizures, especially in patients with lowered seizure thresholds. If you are at risk for seizures, you should not participate in our relaxation sessions.
Magneceutical™ therapy relaxation sessions should not be administered to Patients with the following Health Conditions:
- Implanted electrical stimulators in the Brain
- Chronic Atrial Fibrillation (Uncontrolled)
- CHF (Congestive Heart Failure)
- High Blood Pressure (Uncontrolled)
It is possible that there are other medical risks from exposure to the Magnesphere™ as we do not know all of the consequences from its use. The FDA has not decided that the Magnesphere™ device or exposure to it is safe. It is possible that you may suffer discomfort or pain, but it is not likely.
Since the magnetic therapy 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 that the Company has identified with this device.
To date, five Institutional Review Boards (IRBs), including Independent Review Consulting, Inc. IRB, Western Investigational Review Board (WIRB), University of Colorado's IRB (COMIRB), Ethical & Independent Review Services, and University of South Florida's IRB determined the Magnesphere's™ predecessor device, the Resonator™, to be a non-significant risk (NSR) device when applied to the particular studies and protocols identified below. These protocols involved Parkinson Disease, Alzheimer Disease, Fibromyalgia, and Type 2 Diabetes patients for eight independent studies, as described below:
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 # 07021-02.
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# 07102-01.
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™ for the treatment of Parkinson's Disease: Extension pilot study protocol, Version 4.0, March 14, 2008. IRC# 06052-01.IRC Resonator Device NSR#: DAM-003.
A controlled pilot study of the application of magnetic fields using the Resonator™ in adjunctive management of Type 2 Diabetes; Version 1.8, December 2, 2008; Pico-Tesla Magnetic Therapies, LLC., a subsidiary of APPLIED MAGNETICS, LLC. IRC Study#08165-01
A randomized, double-blind, placebo-controlled study of the application of magnetic fields using the Resonator™ in adjunctive management of Type 2 Diabetes Mellitus, pilot study II. IRC # 09109-01
A multiple site, randomized, double blind, sham-stimulation controlled study of the application of magnetic fields using the Resonator™ device for the treatment of Parkinson's disease; Pico-Tesla Magnetic Therapies, LLC. April 7, 2010. IRC study# 09026:
A single site, randomized, single-blind, placebo-controlled study to evaluate the safety and efficacy of the application of magnetic fields using the Resonator for the treatment of Alzheimer's Disease in addition to standard of care, Pico-Tesla Magnetic Therapies, LLC. October 12, 2010. USF IRB Study # Pro00001676
A randomized, double-blind, placebo-controlled, evaluation of the application of magnetic fields using the Resonator™ device for the treatment of fibromyalgia: pilot study protocol. Pico-Tesla Magnetic Therapies, LLC. November 2, 2010, E&I Review Services Study # 10242-01