FDA & Safety Disclosure

Last updated September 18, 2026  |  Important information regarding FDA registration, clearance status, off-label use, and ASME PVHO certification  |  www.prestigehyperbaric.com

1. FDA Registration, Clearance, and Approval

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 three different things an FDA relationship can mean, because they are routinely confused:

• 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 Clearance (premarket notification under section 510(k)) means the FDA has found the device substantially equivalent to a device already legally on the market. It is not an independent FDA finding that the device is safe and effective. Hyperbaric chambers fall in this category: they are Class II devices under 21 CFR 868.5470, product code CBF, and are cleared rather than approved.
• FDA Approval (premarket approval) means the FDA has reviewed clinical data and determined that the product is safe and effective for a specific, designated use. It applies to Class III devices. Hyperbaric chambers are not FDA-approved devices, and no seller can accurately describe one as such.

Some products sold or used at Prestige Hyperbaric are FDA-registered but are not FDA-cleared or FDA-approved medical devices. Others, including hyperbaric chambers, are cleared but not approved. Understanding these three distinctions is critical before making any purchasing or wellness decision. For a fuller explanation with the primary FDA sources linked, see cleared versus approved, explained.

2. Hyperbaric Chambers & Off-Label Use

The FDA has cleared soft hyperbaric chambers operating at low pressure for a single indication: acute mountain sickness, also called altitude sickness, and that clearance is prescription-only.

Two further points the FDA has stated directly. Hyperbaric chambers are prescription devices. And the FDA has not cleared fabric or soft-sided chambers for use with oxygen tanks or oxygen concentrators; it has warned that combining them creates what it describes as a homemade device carrying a risk of fire and suffocation.

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

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

The 2.5 ATA hard-shell lay-down chamber available at our facility operates at professional-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

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. Why We Do Not Pursue FDA Approval

We are asked directly, and often, whether our chambers are FDA approved and whether we plan to seek approval. The answer is no on both counts, and we would rather explain the reasoning than let the question sit.

As section 1 sets out, a hyperbaric chamber is cleared, not approved, and a clearance covers one specific device used in one specific configuration. Home hyperbaric is not used that way. An owner runs the chamber pressurized with air and breathes concentrated oxygen from a concentrator through a mask — and once concentrated oxygen is introduced, the setup is outside the cleared configuration the badge refers to. That is the gap the marketing hides: the chamber may be cleared while the way it is sold to be used is not, and a shopper who bought on the strength of “FDA approved” was told something that is not true of their situation. We regard that as a misrepresentation of the clearance, so we will not repeat it. Our own service history with supposedly cleared machines has not persuaded us that the badge predicts quality either.

Accordingly, Prestige Hyperbaric makes no claim of FDA approval, clearance, or device registration for the equipment it sells, and does not describe that equipment as a medical device.

9. ASME and PVHO Certification

The chambers we sell are not ASME or PVHO certified. Unlike the approval question above, that is not a criticism of the standard.

ASME PVHO-1 (Safety Standard for Pressure Vessels for Human Occupancy) is a legitimate, high-level engineering certification, and it is reserved for medical equipment and medical-grade clinical hyperbaric chambers. It is a serious standard and we do not minimize it. The home-user models we generally sell are not built to it: soft uprights do not carry ASME PVHO-1, and hard-shell chambers in this price class generally do not either. A chamber that does carry it is a clinical build, and it comes in at a significantly higher price point as a result.

If ASME PVHO certification is what your application requires, that is a different class of machine, and we can source it: clinical, medical-grade units are supplied through our clinical hyperbaric side and quoted individually. Ask us and we will route the request rather than sell you a home unit against a clinical requirement.

We also make no claim of NFPA 99 compliance or certification for any product we sell.

10. Questions?