A prescription is not required for LiveO2 or ExtremeO2 training systems.
Under these regulations are three specific aspects that may cause a device to be regulated as a medical device or pharmaceutical drug:
- Is it used to diagnose, prevent or treat any disease or health condition caused by a claim made by the manufacturer — not true for either LiveO2 or ExtremeO2;
- It does not achieve its purposes through chemical action within the body. Respiration is a natural and essential process that transports oxygen within the body — not chemicals.
- Oxygen is only classified as a drug when used for breathing and is administered by another person. Self administered oxygen, as with LiveO2 and ExtremeO2 training, is not administered by another person; individuals are free to use oxygen as they choose.
The mechanism of LiveO2 and ExtremeO2 products is to enhance the natural oxygenation effects of exercise. It is well understood and generally accepted that exercise helps to prevent and aid recovery from many diseases and health conditions.
There is no need to be specific. Neither exercise nor exercise equipment is regulated by the FDA, even though exercise provides a wide range of health benefits and affects many recognized health conditions.
About Medical Claims
A claim becomes regulated when a manufacturer asserts their brand of exercise equipment has a regulated health effect on a specific condition. Here are examples illustrating the differences:
- Statement: Exercise is good for you.
- Unregulated Statement with a specific condition: Exercise helps prevent heart attacks;
- Medical Advice — Non FDA Regulated: Your doctor tells you that riding your Schwinn 5 miles a day will help you prevent a heart attack. (Your doctor can advise specific exercise, including a specific brand that may be beneficial to you, based on his/her knowledge of your physical needs.)
- FDA Regulated Claim: The Schwinn company prints a brochure that says: “5 miles of riding a Schwinn bicycle every day helps prevent heart attacks.” (Manufacturer + Specific Brand + Specific Condition + Public Statement = FDA Regulated Claim as a medical device.)
The operative principle is that a statement becomes a medical claim when it specifically associates a manufacturers claim to a specific brand regarding a specific health condition in a public statement. The FDA usually requires manufacturers, like Schwinn, in this example, to support truth of the claim in the form in a clinical trial, or credible peer reviewed literature.
This rule protects consumers by preventing manufacturers from making unsupported claims regarding the health effects of their products.
Non Medical Analysis
LiveO2 and ExtremeO2 are exercise enhancers. In affecting the amount of oxygen delivered to your cells during exercise, you can accelerate and improve the results of your exercise.
Since the manufacturer in this case chooses to makes no claims that associate product use to any specific health condition, and because the oxygen is self administered, this device is deemed non-medical.
Would Be Device Classification
If the manufacturer later makes claims, the device would be classified as a Class 1 — low risk device — similar to dental floss.
The second consideration applied by the FDA “risk”. Risk relates to the nature of the risk of product use, or risks associated with product failure during use: Here are the criteria:
- Class I devices are not intended to help support or sustain life or be substantially important in preventing impairment to human health, and may not present an unreasonable risk of illness or injury. (LiveO2 and ExtremeO2 are NOT intended to help or sustain life or be more important than exercise in preventing impairment to human health);
- Class II devices are designed to perform as indicated without causing injury or harm to patient or user.
- Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury.
As a Class 1 device, LiveO2 and ExtremeO2 would be exempt from pre-market certification.