First — LiveO2 is an exercise system that enhances that uses simultaneous exertion with a switchable respiratory mixture. A switch selects between respiratory oxygen mixtures with contrasting air mixtures, each has well established safety norms.
The oxygen-rich mixtures known by divers as Nitrox have a 70 year safety history starting in World War II, and since about 1960 for recreational divers.
Nitrox mixtures have more oxygen and less nitrogen to enable divers to spend more time at deeper depths without decompression.
The oxygen-reduced mixture approximates the aircraft oxygen partial pressure on commercial aircraft.
Both mixtures are within well researched and established safety norms.
Low oxygen training has been popular since 1968 as athletes train at altitude, or using altitude simulators to prepare for competition at the Mexico City Olympics.
LiveO2 enables a user to switch between contrasting oxygen-rich and oxygen-reduced breathing mixtures.
Oxygen-Rich Mixture Safety
The LiveO2 oxygen rich air is at an oxygen partial pressure of 85% with 15% nitrogen.
Oxygen toxicity is impossible with LiveO2 because the oxygen partial pressure is too low; the small amount of nitrogen supports alveolar volume.
Recreational Nitrox use, over the last 60 years, has established the minimum threshold for oxygen toxicity as oxygen partial pressure above 140%.
This partial pressure is impossible at sea level because pure oxygen has an oxygen partial pressure of 100%, 40% below the documented minimum. This means breathing pure oxygen at sea-level cannot create oxygen toxicity.
The LiveO2 oxygen rich mixture is at an oxygen partial pressure of 85% with 15% nitrogen, so it is well within established safety norms.
Oxygen-Reduced Mixture Safety
The oxygen-reduced mixture simulates oxygen partial pressure at an altitude of about 10,000 feet by removal of a fraction of the oxygen. For comparison the oxygen partial pressure in this mixture is slightly lower than the regulatory maximum for cabin pressure in a commercial aircraft, 8000 ft.
This level is well established as safe and is well researched not to cause hypoxia or other adverse physiological effects for air travel participants.
The Switch Effect
Live O2 simply enables an exercising user to switch between these two well established breathing mixtures whilst exercising, from an oxygen-rich to an oxygen reduced mixture.
No Claim as Stand Alone Device
LiveO2 not a stand-alone device. It is always labeled, branded and recommended for use during exercise. It has no effect when used as a stand-alone device.
LiveO2 mechanism of action relies on exercise to establish blood flow to a body compartment.
After blood flow is established a switch to an oxygen rich breathing mixture maximizes oxygen concentration in blood, resulting in increased oxygen delivery to that compartment.
Absent exercise, there is no increase in blood flow any body compartment, hence there is no effect. Absent exercise, or other challenge which increases blood flow to a compartment, LiveO2 has no effect.
This means that stand-alone use of LiveO2 claims no physical effect when used as a stand alone device.
A Review of Regulations
We were unable to determine regulation of any device regulated by the FDA that makes no claims to any physiological benefit when used alone. The closest regulation we could find:
21 CFR I 860.3 (1) … A device is in class I if (i) general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device…
This regulation asserts the to constraints elements:
- A device — suggests the regulation scope applies to a singular, or stand-alone device. Does not appear to apply to devices used in combination.
- effectiveness — Appears to mandate that the device must be intended to produce an effect when used. Devices not intended to produce an effect with stand-alone use do not appear to fall within the apparent intent of the regulation
The term A device is singular. This appears to exclude the intent to regulate combinations of devices which produce a physiological effect when used together. The regulation appears further outside the intended scope of intended regulation because exercise equipment that is not intended for medical purposes, is generally excluded from regulation.
We have thus concluded that LiveO2 does not fit the definition of medical device because it:
- Produces no effect when use alone — thus does not satisfy the statutory criteria for effectiveness;
- Operates within well established safety parameters — thus satisfies the safety requirement;
- Is not intended as a medical purpose.
Exercise equipment intended for medical purposes
Exercise equipment may be considered medical devices depending on intended use. Here are examples:
- 21 CFR 890.5350 (F) References exercise equipment intended for medical purposes. This establishes that exercise equipment may be used as intended for medical purposes. This classification exempts regulation of all exercise equipment not intended for medical use.
- 21 CFR 890.5360 (F) (a) Declares regulation to measuring exercise equipment intended for medical purposes as class II devices . Equipment not intended for non-medical purposes is exempted.
- 21 CFR 890.5370 (F) (a). Declares regulation for non-measuring equipment intended for medical purposes. Equipment not intended for non-medical purposes is exempted.
Certain exercise equipment is cited within 21 CFR as
- 21 CFR 801
- 21 CFR 890 Physical Medicine Devices
Structure Function Claims
FDA regulates devices that limit claims to structure or function. This FDA policy appears not to include classification of exercise devices void of claims from regulation due to avoidance and omission of structure function claims.
Regulatory Criteria Compared
There are multiple means to establish elevated partial pressures of oxygen within the body.
Hyperbaric is a passive means which uses a pressurized capsule to proportionally increase oxygen partial pressure according to gas partial pressures set by the capsule. It does not require activity of the user.
NITROX diving uses an oxygen enriched mixture in the lungs while swimming underwater. Underwater conditions create mechanical pressure and gas pressures. This process is well documented to increase oxygen partial pressures in the body.
LiveO2 uses normal pressure environment using an alternating alternating oxygen-rich and oxygen-reduced mixtures.
Users employ the reduced-oxygen mixture during exercise to establish vigorous respiration and vascular flow. An instant switch under these conditions to the oxygen-rich mixture produces momentary simultaneous maximums of respiration, vascular flow, and oxygen levels.
This level simulates a diver doing vigorous exercise breathing a 36% NITROX mixture at a depth of about 33 feet — while using stationary exercise equipment, in the comfort and safety of dry land while wearing an easily removable mask.