FDA / Legal

OxyHealth chambers are Class 2 medical devices, which require a prescription from a licensed physician. As indicated in our FDA 510(K) clearance, all of our chambers are approved for clinic and home use.

13 FDA Indications for HBOT

1. Air or Gas Embolism

2. Acute Carbon Monoxide Poisoning

3. Gas Gangrene

4. Crush Injury

5. Decompression Sickness

6. Enhancement of Healing in Selected Problem Wounds

7. Exceptional Blood Loss (Anemia)

8. Intracranial Abscess

9. Necrotizing Soft Tissue Infections

10. Osteomyelitis

11. Delayed Radiation Injury

12. Compromised Skin Grafts & Flaps

13. Thermal Burns

FDA regulations require that the chambers be sold to or on the order of a STATE licensed practitioner.