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Disclaimer. We advise you, that the results of these products can not be tested in a "regular" scientific way. Nevertheless there are many satisfied customers worldwide. These products are neither FDA approved nor do they replace medical therapy or supervision. Unit Not Intended For Medical Purposes - The US Food & Drug Administration (FDA) prohibits manufacturers of instruments from making health or therapeutic claims for effects relating to the physical or mental illness being currently treated by members of the medical profession and/or other licensed practitioners unless said instruments have been registered by the FDA.