FDA Statement & Legal Notice

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.

REGULATORY UPDATE

OxyHealth, LLC Pursuant to FDA Warning Letter #406207, OxyHealth has always maintained 510(k) clearance and approval from the FDA to market and retail portable hyperbaric chambers to the public at large, since its inception. Pursuant to FDA regulations, OxyHealth, LLC also maintains the CFG (Certificate to Foreign Goods) license for its soft chambers as well as hard chambers, to retail the product in foreign markets. A CFG license denotes that the company and the products are in compliance.

There are no open complaints or items that need corrective actions per FDA. Latest enquiry by the FDA has been formally cleared according to the April 8, 2014, FDA close out letter.