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Why isn’t LiveO2 a medical device

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:

  1. Pro­duces no effect when use alone — thus does not sat­is­fy the statu­to­ry cri­te­ria for  effec­tive­ness;
  2. Oper­ates with­in well estab­lished safe­ty para­me­ters — thus sat­is­fies the safe­ty require­ment;
  3. 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 

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.

If you feel that there is a state­ment where that con­flict with this pol­i­cy please sub­mit a report on this page.

Updated on August 15, 2019

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