Class II Medical Device Disclaimer
Hyperbaric Chamber – Class II Medical Device Disclaimer
Class II Medical Device Notice
Hyperbaric chambers are classified by the FDA as Class II medical devices, meaning they carry a moderate to high level of risk and require specific regulatory controls to ensure safe operation.
Prescription Requirement
A valid prescription from a licensed physician is required to purchase and operate a hyperbaric chamber.
A prescription must be submitted within 30 days of purchase.
FDA Compliance
Hyperbaric Oxygen Therapy (HBOT) is FDA-approved for a limited number of medical conditions. Marketing or using a hyperbaric chamber for conditions not cleared through the FDA 510(k) process is considered off-label and is not permitted.
Examples of FDA-Approved Uses
HBOT is FDA-approved for specific conditions, including but not limited to:
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Carbon monoxide poisoning
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Certain non-healing wounds
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Gangrene
Types of Hyperbaric Chambers
There are two primary categories:
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Medical-grade chambers: FDA-approved and capable of reaching pressures up to 3.0 ATA.
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Non-medical-grade chambers: Not FDA-approved and typically not covered by insurance.
NFPA Guidelines
The National Fire Protection Association (NFPA) regulates hyperbaric facility and chamber safety under Chapter 14 of NFPA 99 – Health Care Facilities Code.
Chamber Classifications
Hyperbaric chambers may be categorized as:
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Class A: Multi-occupant chambers
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Class B: Single-occupant chambers
Customer Acknowledgment & Responsibility
By placing your order, you agree to the following:
My physician has prescribed this product for my medical condition. I will read and follow all manufacturer instructions included with the device. I acknowledge and accept full responsibility for the use or misuse of this hyperbaric chamber. If any adverse reaction occurs, I will discontinue use and contact my physician immediately. By clicking “Add to Cart,” I confirm my agreement to these terms.
A prescription for this unit must be submitted within 30 days of purchase.