FDA Statement & Legal Notice - OxyHealth Europe

FDA Statement & Legal Notice

OxyHealth™, LLC chambers are approved by the FDA as class II medical devices, which require a prescription from a licensed physician. As indicated in OxyHealth™, LLC’s FDA 510(K) clearance, all 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™, LLC 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. No violation was present and no corrective actions were taken, as OxyHealth™, LLC invariably sustains legal and ethical business practices to ensure lawful amenability towards consumer compliance in accordance with FDA rules and regulations. OxyHealth™, LLC has been formally cleared according to the April, 8 2014 FDA Close Out Letter.

FDA 510(k) Clearance #K041007 for Fortius420®

* Solace210®, Respiro270®, Vitaeris320®, Quamvis320® and Fortius420® are federally registered and trademarked names of Oxy-Health, LLC and are fully protected under federal law.