1  -  A  PEMF  DEVICE  DOES  NOT  DIAGNOSE-TREAT-or-CURE.  

 

A PEMF device, like the iMRS, diagnoses, treats, or cures nothing -- it simply augments the body's native energy, as part of a healthy lifestyle, to facilitate repair, foster overall general wellness and well-being, promote relaxation, and perhaps improve speed and endurance.

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Accordingly, nothing in my written or verbal communication with you is intended to diagnose, treat, or cure any disease whatsoever. Said communication is merely a reflection of my lay opinions based on my anecdotal experience and web research, and is only designed to complement your own independent research. I could be wrong. I am not a medical doctor. Before applying any of my advice, products, or protocols, you should independently confirm the validity of said information and/or consult with a medical doctor, as appropriate to your situation and medications. If you do apply said advice, products, or protocols, you do so at your own risk and no express or implied warranty as to outcome or results is given.

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  2  -  FDA  DEFINITION  OF  "GENERAL  WELLNESS  DEVICE".    click  

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Note: "This guidance represents the current thinking of the Food and Drug Administration (FDA) on this topic. It does not establish any rights for any person and is not binding on FDA or the public." "The use of the word should in Agency guidance means that something is suggested or recommended, but not required."

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The FDA "defines general wellness products as products that meet the following two factors: (1) are intended for only general wellness use, as defined in this guidance, and (2) present a low risk to the safety of users and other persons."

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A general wellness device is automatically NOT low risk and NOT covered by this guidance if it ~

 

1. Is INVASIVE.

2. Is IMPLANTED.

3. Poses a RISK to the safety of users and others, if specific regulatory controls are not applied, as in the case of lasers or

    radiation exposure.

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"A general wellness product, for the purposes of this guidance, has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition."

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Thus, a general wellness product, MAY make claims about sustaining or offering general improvement to functions associated with a general state of health that do NOT make any reference to diseases or conditions.  For example ~

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-- Claims to promote or maintain a healthy weight, encourage healthy eating, or assist with weight loss goals.

-- Claims to promote relaxation or manage stress.

-- Claims to increase, improve, or enhance the flow of qi “energy”.

-- Claims to improve mental acuity, instruction following, concentration, problem-solving, multitasking, resource manage-

   ment, decision-making, logic, pattern recognition, or eye-hand coordination.

-- Claims to enhance learning capacity.
-- Claims to promote physical fitness, such as to help log, track, or trend exercise activity, measure aerobic fitness, improve

   physical fitness, develop or improve endurance, strength or coordination, or improve energy.

-- Claims to promote sleep management, such as to track sleep trends.

-- Claims to promote self-esteem, such as to boost self-esteem.

-- Claims that address a specific body structure or function, such as to increase or improve muscle size or body tone,

   tone or firm the body or muscle, or enhance or improve sexual performance.

-- Claims to improve general mobility or to assist individuals who are mobility impaired in a recreational activity (e.g., sport

   wheelchairs, beach access wheelchairs).

-- Claims to enhance an individual’s participation in recreational activities by monitoring the consequences of participating

   in such activities, such as to monitor heart rate or monitor frequency or impact of collisions.

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Further, a general wellness product may make claims that it, as part of a healthy lifestyle, "may help to reduce the risk of" or "may help living well with" certain chronic conditions or diseases ~

 

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However, a general wellness product may NOT make any of the following claims, for example ~

 

-- A claim that a product will treat or diagnose obesity.

-- A claim that a product will treat an eating disorder, such as anorexia.

-- A claim that a product helps treat an anxiety disorder.

-- A claim that a computer game will diagnose or treat autism.

-- A claim that a product will treat muscle atrophy or erectile dysfunction.

-- A claim to restore a structure or function impaired due to a disease or condition, e.g., a claim that a prosthetic

   device enables amputees to walk.

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