Clinical HyperbaricLifemax Chambers

Effective date: May 1, 2026

FDA & Safety Disclosure

Please read this disclosure in full before purchasing or operating any Clinical Hyperbaric equipment. The information below is critical to your understanding of the products offered by Clinical Hyperbaric.

1. FDA-Approved vs. Non-FDA-Approved Products

Clinical Hyperbaric sells and provides access to a range of equipment including soft hyperbaric chambers and hard-shell hyperbaric chambers. It is important to understand the distinction between FDA-registered and FDA-approved products:

  • FDA Registration means that the manufacturer has notified the FDA of the product's existence and certain details about it. Registration doesnot mean the FDA has evaluated the product for safety or effectiveness.
  • FDA Approval means the FDA has reviewed clinical data and determined that the product is safe and effective for a specific, designated use.

Some products sold or used at Clinical Hyperbaric are FDA-registered but are not FDA-approved medical devices. Understanding this distinction is critical before making any purchasing or wellness decisions.

2. Hyperbaric Chambers & Off-Label Use

The FDA has approved soft hyperbaric chambers operating at 1.3 ATA (atmospheres absolute) for a single indication: altitude sickness. Any other use of a soft hyperbaric chamber — including general wellness, athletic recovery, performance enhancement, anti-aging, cognitive support, chronic conditions, or any other purpose — constitutes off-label use.

Off-label use means the FDA has not evaluated the safety or effectiveness of that product for that particular use. Off-label use is not illegal; however, claims about effectiveness in those areas have not been validated by the FDA and may not be supported by sufficient clinical evidence.

Clinical Hyperbaric does not make FDA-backed claims regarding the effectiveness of hyperbaric oxygen therapy for any condition other than altitude sickness.

3. No Medical Claims

Unless specifically stated for a confirmed FDA-approved product and its FDA-approved indication, the following applies to all equipment and content offered by Clinical Hyperbaric:

  • The FDA has not evaluated the products or statements appearing on www.clinicalhyperbaric.com.
  • The equipment and services offered are not intended to diagnose, treat, cure, or prevent any disease or medical condition.
  • All content on this website is informational and educational in nature only.
  • Nothing provided by Clinical Hyperbaric — written, verbal, or implied — constitutes or should be construed as medical advice.
  • Our content is never a substitute for professional medical advice, diagnosis, or treatment from a licensed healthcare provider.

4. Consult a Healthcare Professional

We strongly encourage every client and prospective buyer to speak with a qualified, licensed healthcare provider before:

  • Beginning any hyperbaric oxygen regimen with this equipment.
  • Purchasing or operating any chamber sold by Clinical Hyperbaric.
  • Making purchase or use decisions based on testimonials or general educational material published on this site.

This is especially important for individuals with pre-existing medical conditions, those taking prescription medications, pregnant or nursing individuals, and anyone who has recently undergone surgery or medical procedures.

5. Hard Shell Chambers at 2.5 ATA

A valid prescription from a licensed physician is required to use the 2.5 ATA hard-shell chamber. No exceptions.

The 2.5 ATA hard-shell chamber operates at medical-grade pressure levels and is sold only to qualified buyers. Purchase and operation of this chamber require the following:

  • A valid, current prescription from a licensed physician must be on file with the operator before the chamber is used by any patient or client.
  • The physician's documented treatment protocol must accompany every prescription and remain on file with the operator.
  • Clinical Hyperbaric's role is limited to equipment sale, installation, and service. We are not present in a medical capacity and do not provide medical care, oversight, supervision, or treatment guidance.
  • The buyer and operator assume full liability for all use of this equipment under the prescribing physician's protocol.

6. Testimonials Disclaimer

Customer testimonials, reviews, and personal accounts shared on this website or through our marketing materials reflect the individual experiences and opinions of those clients. They are not representative of all users, are not guarantees of results, and may not apply to your specific situation.

Testimonial statements have not been evaluated by the FDA and do not constitute medical claims or endorsements of any product or service for medical use.

7. In-Chamber Electronics & Fire Risk

🔥 CRITICAL FIRE HAZARD — Hyperbaric chambers contain elevated concentrations of oxygen. Introducing any electronic device, battery, lighter, or spark-producing item creates a serious and potentially fatal fire and explosion risk. This is a zero-tolerance safety policy. No exceptions.

In a hyperbaric oxygen environment, the risk of fire is dramatically elevated compared to normal atmospheric conditions. Common items that are absolutely prohibited inside any hyperbaric chamber include, but are not limited to:

  • Cell phones, smartphones, and tablets
  • Smart watches and fitness trackers
  • Hearing aids and cochlear devices
  • Any battery-powered device of any kind
  • Lighters, matches, or any flame-producing item
  • Loose batteries (AA, AAA, rechargeable, or any other type)

All items brought into or near the chamber must be inspected and explicitly approved by trained staff before any session begins. If you are uncertain about any item, leave it outside the chamber. This rule exists to protect your life and the lives of others in the facility.

8. Questions?

If you have any questions about this FDA Disclosure or the products we offer, please reach out to us directly: