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Intended Use

This reference asserts the intended uses of LiveO2, and provides a feedback form to report content which does not comply with our policy.

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Intended Use No Discrimination Oxygen Deficiency Research Indirect Effects of Oxygen No Effect for Stand Alone Use Un-Intended Use No Refunds Policy Exception with Medical Claim Report Medical Claim Report

Intended Use

The intended effect and mechanism of LiveO2 is only intended to improve the effects of exercise. The mechanism of action relies exclusively on the user’s natural respiratory process to deliver oxygen to tissue inherent to exercise.

LiveO2 is intended to enable users to:

  1. Optimize endurance training. The low-oxygen selection enables a user to increase the functional intensity of exercise by a simulated altitude. This is equivalent to well established hypoxic training systems.
  2. Optimize strength training. The high-oxygen selection enables a user exert at elevated intensity enabled by rich oxygen mixture.
  3. Accelerate training effects. Post sprint recovery with rich oxygen enables users quickly recover from sprints for rapid-fire training which produces more results in less time.
  4. Maximize tissue oxygen levels.

Exercise is well understood and accepted to increase the amount of oxygen delivered to a tissue. Increased oxygen from exercise is well documented to optimize energetic performance of tissue – which normally have a beneficial effect to optimize cellular energy production.

The energetic performance of tissue indirectly governs health as resistance to disease and healing.

Exercise is well understood to improve the structure and function of tissue because it increases oxygen. These effects occur regardless of any disease state that may affect the tissue.

No Discrimination

We cannot discriminate or refuse to sell a product to a person who identifies they may have a medical condition.

Our sales and support process are purely intended to enable LiveO2 customers to maximize oxygen levels in their body.

Any effect on a disease condition is not the intended effect of product use. Any process or product which increases the oxygen concentration within the tissue would have the same effect, notably Hyperbaric Therapy.

Oxygen Deficiency Research

Several pages on this site provide functional guidance relating to methods of exercise and product use. The intent of this content is to:

  1. Enable the visitor to access relevant research literature relating disease conditions to oxygen deficiency
  2. Suggest exercise and other methods which may enable the user to improve the oxygen levels of particular tissues
  3. Provide any research/support that supports why the suggested exercise method is likely to increase oxygen available to the tissue
  4. When possible provide subjective and objective analytical tools to enable users to assess the results of the methods used
  5. Enable users to provide community feedback as to the effect of the methods
  6. Enable users to review subjective and objective results from others

Indirect Effects of Oxygen

LiveO2 may have an effect on any health condition is an indirect result of improved energy status due to the effect of increasing the oxygen available to the tissue. This increased energy status is the well recognized effect of exercise. LiveO2 increases the beneficial effects of exercise.

Any effects are the results of simultaneous physiology:

  1. An exercise device to activate blood flow and oxygen delivery to a tissue
  2. LiveO2 on +O2 (oxygen rich air) to increase the oxygen in the blood, both plasma and hemoglobin
  3. LiveO2 on -O2 (oxygen reduced air) to increase the vascular flow directed to particular tissues
  4. Switch from -O2 to +O2 to create maximum tissue oxygenation resulting from simultaneous maximum of blood flow and oxygen concentration

All of these effects are generally derived from the exertion and recovery cycle element High Intensity Interval Training. They are within recognized benefits of exercise.

No Effect for Stand Alone Use of LiveO2

LiveO2 is only intended for use with exercise or physical challenge that increases blood flow. All supporting collaterals direct users to conduct some form of exertion while using LiveO2. These include but are not limited to:

  • Physical exercise on exercise equipment
  • Hyperthermia in a sauna
  • Hypothermia in a cold bath

Any benefit that a user experiences will only occur when at least one form of physical challenge is used with LiveO2. Absent this stimulation there is nothing to activate blood flow from the lung to a target tissue, so no benefit will occur.

Un-Intended Use

LiveO2 is not intended for use in any medical condition. It is not intended to treat, mitigate, cure, prevent or have any effect whatsoever on any medical or health condition.

No Refunds for failure to have an effect on Medical Condition

LiveO2 must decline all requests to accept returns because the product failed to cause a beneficial effect on a specific health condition.

Providing a refund because LiveO2 failed to cure any health condition could be interpreted to be an implied warranty because it implies a warranty that the product will have an effect on a health condition. This could cause LiveO2 to be considered a medical product.

Exception with Medical Claim Report

Refunds are allowed when customer purchased our product because we made any statement which would be reasonably deemed to be a medical claim.

To qualify for this exception, the customer must notify us of our error with the medical claim report form, below. This form helps us correct our publications to avoid medical claims, and avoid future claims.

If you purchased our product because you feel we made a medical claim, our policy is to allow the refund for any statement that fits the statutory definition of a medical claim, language below.

Name
Reason for Refund Request(Required)
You are entitled to a refund if a public LiveO2 document created a medical claim which led you to believe that you would achieve a medical benefit. We need to know what publication led to your misunderstanding.
Please explain which part of LiveO2 Intended Use Statement is unclear or failed to explain what you should, and should not expect from LiveO2 use.
LiveO2 cannot issue a refund because you believed it should create a medical benefit for you or someone else. Issuing a refund on this basis would be to make an implied medical claim and could cause LiveO2 to be considered a medical product because of an implied claim. If our staff communicated with you to believe that LiveO2 would have a health benefit without explaining that usage is experimental.

Medical Claim Report

Please report any content or statement which appears to claim a medical benefit from LiveO2 use, or which mislead a user to believe LiveO2 may create a medical benefit when used alone.

The FDA defines a medical device as:

  • “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

Please Report any statement that:

  1. Directly associates use of LiveO2 with a medical benefit, or
  2. Does not describe use a combination of an exercise or thermal device along with LiveO2 to activate energy metabolism to produce a health benefit, or
  3. Does not support the role of oxygen deficiency as the basis of any referenced condition, or
  4. Mislead you to conclude that LiveO2 is a medical device by making any statement inconsistent with FDA statutes regarding medical devices.

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