Complaint Responses

Cherise E Complaint

Prompted by

Do you know the physics and physiology of Hyperbaric Oxygen Therapy? 

Hyperbaric Oxygen Therapy increases Oxygenation by an average of 2,000 times not 4 times as your system does.

The oxygen you breathe exercising while using oxygen is immediately utilized by the body during exercise and not being used to heal specific medical conditions. Certain aspects of your website state this is just a way to increase output during exercise yet claiming the use is similar to Hyperbaric Oxygen Therapy is a flat out lie.

The statements being made to contrast Live O2 to Hyperbaric Oxygen Therapy are very misleading. I just had someone call me and tell me that Live O2 is better than Hyperbaric Oxygen Therapy. Hyperbaric Oxygen Therapy is an FDA approved modality with extensive Journals of Medical studies treating many medical conditions.

LiveO2 Response 

Regulatory Claim Analysis:

The statutory definition of a claim asserts an intended benefit of a branded product use toward a specific disease condition. No statements in the article appear to meet the statutory definition of a medical claim are found. A medical claim must name a disease condition intended to be affected by product use. No medical conditions are mentioned in the article you cited.

Deficiencies in the essentials for life like food, water and air are not by themselves medical conditions. Resolving a deficiency, as a basis for continued life, is simple survival. Failure to supply or provide any life-essential substance is deemed inhumane within FDA statutes. 

Any able person is obliged to provide and support substances essential to life. Since thirst, hunger and suffocation do not meet the statutory definition of medical conditions, FDA regulations are silent - except anyone able is compelled to render aid and assistance.

This makes sense or else restaurants and water fountains would be deemed medical facilities. Air would be a medical substance. 

The FDA describes 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.

LiveO2 does not fit the statutory definition of a medical device:

  1. It is clearly and repeatedly labeled as not intended for the use in the diagnosis use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animal;
  2. It IS intended to affect the structure or function of the body and it DOES achieve its intended primary purpose with chemical action (supplying oxygen as a metabolite) to be metabolized for its intended purpose.

Discussion of LiveO2 relative to HBOT by mechanism delivery of oxygen to tissue, or relative efficiency of tissue oxygen delivery does not make LiveO2 a medical device.

Is HBOT a medical treatment?

Sometimes yes, sometimes no.

In many uses, HBOT technically does not qualify as a “medical” treatment because it delivers an essential nutrient, oxygen, to tissue. Use of “pressurized air” for improved health - by itself NOT fit the statutory definition of a medical application. 

HBOT has a modest dangers:

  1. Rapid depressurization from rupture, opening or door failure can cause ear injury;
  2. Alveolar rupture, lung injury, can occur if a user holds their breath during depressurization;
  3. Nitrogen absorption can result in bends if a user flies on an aircraft soon after treatment;
  4. Captive users may panic because the containment must be depressurized prior to exit.

These modest risks contribute to the reasons why HBOT is regulated as a medical device regardless of intended use.

When is HBOT a medical treatment?

HBOT becomes a medical device when manufacturer represents it having a benefit for a specific medical condition. A statement that associates a branded device with a benefit is called a claim

A claim is a statement that expresses benefit with the intent to establish a confidence the device will perform as represented for the medical condition. Devices that make medical claims require regulatory approval because to assure the claim is legitimate and dangers of use are reasonably mitigated. 

A general claim but asserts a general benefit like improved energy, is a Structure Function Claim. These do not require FDA approval and were established in the DSHEA act of 1994

Oxygen enables cells to produce energy is a structure function claim - the truth of this self evident and any device like HBOT or LiveO2 that improves oxygen provides a benefit - but creation of the benefit does not make the device a medical device.

Why is LiveO2 training?

There are four reasons:

  • LiveO2 does not work alone. We express “training” because exercise is always required. LiveO2 does not work by itself. HBOT, when used as a medical treatment, does.
  • No Medical Claims. LiveO2 never uses the word “treatment” because “treatment” asserts the product is intended to be used for a particular medical condition. No public statement that I am aware asserts or implies that LiveO2 will have a benefit for a specific medical condition. LiveO2 is never described as a treatment.
  • LiveO2 makes the positive “Structure and Function” claim of improvement of oxygen in the body.  Structure and function claims assert improvement in well being. LiveO2 specifically claims to increase oxygen levels in the body. Since oxygen is essential for life and health, and since this is easily verified the claim is accurate.

Why are LiveO2 risks less than HBOT?

LiveO2 does not use pressure. A user can exit anytime or stop exercising.

LiveO2 does not present any of the risks inherent with HBOT because there is no pressure.

The only risk is that which is inherent to whatever form of exercise the user chooses to do. Our instructions advise users exercise responsibly, or under medical guidance, if they deem it necessary.

Does LiveO2 increase oxygen more than HBOT?

Yes - but you must differentiate oxygen availability versus actual oxygen used for energy production.

HBOT References that cite oxygen delivery and utilization are ambiguous at best. The references cited (Ardenne) depict and measurement differential oxygen sensor equipment which precisely measure arterial/venous plasma dissolved O2 differentials. This directly measures oxygen utilization, thus energy production.

We have validated this by testing VO2-max. Volunteers gain over 5% durable oxygen use, and energy production within about a week per VO2-Max testing. Over 11 weeks, the subject gained 29% increase in energy production. We feel this test validated the exhaustive research by Ardenne.

As far as we have found - there are no HBOT related references that calibrate HBOT therapy to the body’s durable ability to produce energy.

HBOT temporarily increases tissue metabolism proportional to the increase oxygen levels for the duration of increase of O2 partial pressure at the target tissue. This results in a temporary increase to the energy production which facilitates healing. Normal HBOT treatments require 40+ dives averaging 1-2 hours for a chamber dwell time exceeding 80 hours.

With HBOT the increase in tissue energy production persists until the O2 level returns to normal, normally a few hours at best.

Why the difference in tissues?

In most cases the target tissue is distinct from the lungs so oxygen must enter the blood and the blood must travel to the tissue, and deliver the oxygen.

The Ardenne references clearly explain the difference between plasma saturated O2 versus hemoglobin bound O2. Both LiveO2 and HBOT rely on plasma dissolved O2. LiveO2 is well differentiated from HBOT because it achieves the capillary switch threshold of 12 CC/L which restores blood flow through stress-injured capillaries. Exercise with LiveO2 and Adaptive Contrast maximizes pulse pressure to deliver oxygen within high resistance flow networks (injured tissues) within the body.

This is well documented in the citations above. HBOT does not achieve these levels due to O2 partial pressure limitations at the venous end of the capillaries. HBOT does not achieve the 12 CC/L (4 ATM) threshold O2 plasma concentration to achieve Ardenne's switch threshold.

The reference you mention speaks to enabling an increase of the systemic oxygen level, particularly to increase the partial pressure of oxygen dissolved in body fluids versus oxygen present in the lungs. I have clarified the language to differentiate oxygen levels by tissue from HBOT and LiveO2 in lung versus tissue. 

To be clear, LiveO2 is inferior to HBOT for medical treatment for individuals incapable of exercise. LiveO2 is not branded, marketed or represented to provide any medical benefit for any medical condition. 

To be more clear, LiveO2 is a training system.  When used according to labeling and instructions LiveO2 delivers more oxygen to tissues than HBOT, and creates a durable improvement in energy production that HBOT cannot.