Hyperbaric Chamber Disclaimer

Medical Device Classification

Hyperbaric Chamber Disclaimer: Hyperbaric chambers offered by Hyperbaric Health are considered Class II medical devices by the U.S. Food and Drug Administration (FDA). Our medical team can assist if you are in need. Ask a team member for more information.

Prescription Requirement

Important: A valid prescription from a licensed physician is required for the purchase and use of a hyperbaric chamber.

  • You must submit a prescription within 30 days of purchase.
  • Use of the chamber without a physician’s supervision or prescription is strictly prohibited and may be unsafe.

Our medical team can assist if you are in need. Ask a team member for more information.

FDA Approval & Legal Use

The FDA has approved Hyperbaric Oxygen Therapy (HBOT) for the treatment of specific medical conditions only. Marketing or promoting the use of HBOT for any condition that is not explicitly approved by the FDA, or not cleared through the 510(k) process is considered off-label.

For a full list of FDA-approved conditions, please consult the FDA website.

Examples of FDA-Approved Conditions

  • Carbon Monoxide Poisoning
  • Decompression Sickness
  • Gas Embolism
  • Gangrene
  • Chronic non-healing wounds

Examples of Off-label are endless

  • Anti-Aging
  • Alzheimer’s
  • Anoxic brain injury
  • Arthritis
  • AthleticRecovery
  • Cancers
  • Cerebral palsy
  • ChronicPain
  • Colitis
  • Chronos
  • Neurological
  • Psoriasis & Eczema
  • Fibromyalgia
  • LymeDisease
  • Migraines
  • PTS
  • TBI
  • Pre/PostSurgery
  • StrokeRecovery
  • Tinnitus

Types of Hyperbaric Chambers

Hyperbaric chambers fall into two primary categories:

1. Medical-Grade Chambers

  • FDA-approved
  • Typically reach pressures of up to 3.0 ATA
  • Can be covered by insurance when prescribed for FDA-approved uses

2. Non-Medical Grade Chambers

  • Not FDA-approved
  • Lower pressure capacity
  • Not eligible for insurance coverage
  • Intended for wellness or investigational use only

NFPA Safety Standards

All hyperbaric chambers and facilities should comply with standards set by the National Fire Protection Association (NFPA). NFPA 99 – Health Care Facilities Code, Chapter 14, provides detailed guidelines for the safe installation and operation of hyperbaric systems.

We provide comprehensive training for all units we offer. Ask a team member for more informaiton.

Chamber Classifications

  • Class A Chambers: Designed for multiple occupants
  • Class B Chambers: Intended for single occupant use only

User Agreement Disclaimer

By placing an order with Hyperbaric Health, you agree to the following:

“I certify that my physician has prescribed this product for the treatment of a specific medical condition. I have read and will follow all manufacturer instructions for use. I accept full responsibility for the proper or improper use of the hyperbaric chamber. I understand that if I experience any unusual or adverse effects, I will immediately consult with my physician. By clicking ‘Add to Cart,’ I affirm that I understand and accept the terms outlined above.”

Note: A valid prescription must be submitted within 30 days of purchase.

If you have any questions or concerns about the legal or safe use of hyperbaric chambers, please consult your healthcare provider or contact us directly.