Hyperbaric Chamber Class 2 Medical Device Disclaimer
Class II Devices
The FDA categorizes Class II medical devices as those with moderate to high risk to the patient or user, and the majority of medical devices fall into this category.
Perscription Required
Hyperbaric chambers cannot be sold or used without the prescription of a licensed physician. A prescription for this unit must be submitted within 30 days of purchase.
FDA Approval
The FDA has approved hyperbaric oxygen therapy (HBOT) for specific medical conditions, and marketing a hyperbaric chamber for any indication not listed and not cleared through the 510(K) clearance process is considered off-label and illegal.
Examples of FDA-Approved Conditions
Some of the conditions for which HBOT is FDA-approved include: carbon monoxide poisoning, gangrene, and wounds that won't heal.
Types of Hyperbaric Chambers
There are two main types of hyperbaric chambers: medical grade and non-medical grade. Medical grade chambers are FDA-approved and can reach pressures of 3.0 ATA, while non-medical grade chambers are not FDA-approved and are not covered by insurance.
NFPA Standards
The National Fire Protection Association (NFPA) has standards for hyperbaric facilities and the chambers within, which are found in Chapter 14 of NFPA 99, Health Care Facilities Code.
Class A and Class B chambers
Hyperbaric chambers can be classified as Class A (multiple occupants) or Class B (single occupant).
Disclaimer: By placing your order, you must agree to the statement below:
My physician has prescribed this product for my medical condition. I will read and carefully follow the manufacturer's directions provided with the product. I assume all responsibility for the use/misuse of this Hyperbaric Chamber. I will contact my physician immediately in the case of any untoward reactions caused by use of this product. By clicking "Add to Cart" you certify your acceptance of the above statement.
*A prescription for this unit must be submitted within 30 days of purchase.*
