Classification: Class II Medical Device
The U.S. Food and Drug Administration (FDA) classifies hyperbaric chambers as Class II medical devices. These devices are considered to pose moderate to high risk to users and require compliance with specific regulatory standards, including physician oversight and a valid prescription for use.
Prescription Requirement
Per FDA regulations, this product requires a prescription from a licensed physician prior to use. By purchasing this unit, you acknowledge and agree that:
-
You have obtained or will obtain a valid prescription.
-
You understand that this device should be used only under medical supervision.
-
You will submit your prescription within 30 days of purchase.
FDA Clearance & Intended Use
The FDA has cleared hyperbaric oxygen therapy (HBOT) for a limited number of medical conditions. It is unlawful to market or use this device for any unapproved indications that have not received FDA 510(k) clearance.
Examples of FDA-Cleared Indications for HBOT include:
- Air and gas bubbles in blood vessels
- Anemia (severe anemia when blood transfusions cannot be used)
- Burns (severe and large burns treated at a specialized burn center)
- Carbon monoxide poisoning
- Crush injury
- Decompression sickness (diving risk)
- Gas gangrene
- Hearing loss (complete hearing loss that occurs suddenly and without any known cause)
- Infection of the skin and bone (severe)
- Radiation injury
- Skin graft flap at risk of tissue death
- Vision loss (when sudden and painless in one eye due to blockage of blood flow)
- Wounds (non-healing, diabetic foot ulcers)
For the full list of approved indications, please refer to the official FDA HBOT guidance.
Types of Hyperbaric Chambers
There are two general types of hyperbaric chambers:
-
Medical Grade Chambers:
FDA-cleared, capable of reaching up to 3.0 ATA, and typically used in clinical settings. These may be covered by insurance when prescribed for an approved condition. -
Mild (Portable) Chambers:
Designed for personal use, generally operating at pressures up to 1.5 ATA, and not covered by insurance. Usage still requires a valid prescription and oversight from a licensed provider.
NFPA Standards & Chamber Classes
The National Fire Protection Association (NFPA) outlines safety guidelines for hyperbaric facilities and chambers under NFPA 99: Chapter 14 – Health Care Facilities Code.
-
Class A Chambers: Designed for multiple occupants.
-
Class B Chambers: Designed for a single occupant and more commonly used for personal or home use.
Important Legal Disclaimer
By placing an order for this hyperbaric chamber, you must agree to the following:
I confirm that a licensed physician has prescribed this device for my use. I understand that it is my responsibility to use the product according to all manufacturer instructions and under appropriate medical supervision. I assume full responsibility for the use and outcome of this product, and I will contact my physician in the event of any adverse reactions.
Note: A valid prescription must be submitted within 30 days of purchase.