FDA & Safety Disclosure

Important information regarding FDA registration, approval status, and off-label use | www.prestigehyperbaric.com

Please read this disclosure in full before purchasing any equipment or beginning any wellness session. The information below is critical to your understanding of the products and services offered by Prestige Hyperbaric.

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

Prestige Hyperbaric sells and provides access to a variety of wellness products including soft hyperbaric chambers, red light therapy panels, PEMF mats, infrared saunas, and cold plunge systems. 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 does not 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 Prestige 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.

Prestige 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, sessions, and content at Prestige Hyperbaric:

The FDA has not evaluated the products or statements appearing on www.prestigehyperbaric.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, in our facility, or communicated by our staff is informational and educational in nature only.
Nothing provided by Prestige Hyperbaric — written, verbal, or implied — constitutes or should be construed as medical advice.
Our content and services are 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 or wellness regimen.
Purchasing or operating any equipment sold by Prestige Hyperbaric.
Making wellness decisions based on testimonials, blog content, 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 lay-down chamber available at our facility operates at medical-grade pressure levels. Access to this chamber is only permitted under the following conditions:

A valid, current prescription from a licensed physician must be on file before the client's first session.
The physician's documented treatment protocol must accompany the prescription.
Prestige Hyperbaric's role is equipment access only — comparable to renting or leasing equipment from any vendor. We are not present in a medical capacity and do not provide medical care, oversight, supervision, or guidance.
The client assumes full liability for all use of this equipment under their 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 and services we offer, please reach out to us directly: