Why Isn't cryotherapy FDA approved?

If cryotherapy is safe, why isn't cryotherapy FDA approved? As you do your research on cryotherapy there might be some common questions or objections that need to be answered. A Japanese doctor invented cryotherapy in the 1970's for arthritis treatment. In the late 1980s, Europe caught on and made cryotherapy chambers for the whole body. By the turn of the century, American athletes were using it. The United States is now the leading cryotherapy market in the world.

Is Cryotherapy Dangerous?

The FDA building where medical devices are reviewed

A common objection about cryotherapy is that it is not FDA approved and is thus "dangerous." But the FDA does not regulate cryotherapy. The FDA does not approve any cryo chamber because they are not medical devices. Also, cryotherapy never claims to treat any disease or illness. However, the FDA does recognize some chambers as a FDA 513(g) devices. This means that it meets the precise manufacturing standards set out by the FDA. This is an FDA acknowledgment that the quality of the manufacturing meets its strict criteria. Moreover, the United States government approved the XR cryosauna for GSA contracts. Unlike other chambers it meets the requirements for military and government purchasing.

Is Liquid Nitrogen Dangerous?

The FDA has warned against the use of liquid nitrogen in foods and therapy, since it has the potential to be misused. For this reason, our chambers have 8+ safety features that act as safeguards against any potentially harmful interaction with nitrogen. The XR cryotherapy chamber is the only chamber to use Dual Fingerprint Authentication to ensure that a trained professional is operating the machine and remains present for each session. This means that the operator and client both have to sign in using fingerprints, preventing no unsupervised or unauthorized sessions.

Invest in Safety First

The XR is the safest chamber available

It is understandable that you may be apprehensive about purchasing a cryotherapy chamber. However, the XR is the top of the line in terms of safety and regulations. No other chamber provides as many safety features. In fact, safety with the XR becomes redundant in that it is impossible to start, continue, or finish a session that might become dangerous. How? The XR's 8+ safety features require the client and the operator to simultaneously follow the integrated safety features for the entire session. The client cannot begin a session without affirming they are healthy and are wearing the appropriate safety gear. The operator must be certified to run the session and must remain observing the chamber for the entire session.

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Learn more about the benefits of cryotherapy and go through the many cryotherapy clinical studies.

NOTICE: Information contained within this website and on all materials, communications, or presentations by Cryo Innovations and Cryo Recovery Lounge is for informational purposes only.  Whole Body Cryotherapy, infrared sauna, hyperbaric chamber, and any and all recovery methods described and/or offered by Cryo Recovery Lounge or Cryo Innovations are neither designed nor advised for treatment or cure of any illness or disease.  No cryotherapy chambers (including the XR) have been tested or approved by the FDA.  Please consult with your medical professional before beginning any cryotherapy or recovery method.  All material contained within this site is copyrighted and may not be reproduced in any form without prior written permission. All rights reserved. For permissions contact Cryo Innovations.