FDA Statement & Legal Notice
OxyHealth chambers are a Class II medical device. As indicated in the FDA 510(K) clearance, these chambersóboth the portable mild and steel typesóare prescription devices.
The mild portable chambers are cleared for the treatment of oxygen deficiency due to Acute Altitude Sickness (also known as AMS).
The steel chamber is cleared for the treatment of 13 recognized indications, which are:
- Air or Gas Embolism
- Carbon Monoxide Poisoning
- Carbon Monoxide Poisoning Complicated by Cyanide Poisoning
- Clostridal Myositis and Myonecrosis (Gas Gangrene)
- Crush Injury, Compartment Syndrome, and other Acute Traumatic Ischemias
- Decompression Sickness
- Enhancement of Healing in Selected Problem Wounds
- Exceptional Blood Loss (Anemia)
- Intracranial Abscess
- Necrotizing Soft Tissue Infections
- Osteomyelitis (Refractory)
- Delayed Radiation Injury (Soft Tissue and Bony Necrosis)
- Skin Grafts & Flaps (Compromised)
- Thermal Burns
FDA regulations require that the chambers be sold to or on the order of a state licensed practitioner.
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. No violation was present and no corrective actions were taken, as OxyHealth invariably sustains legal and ethical business practices to ensure lawful amenability towards consumer compliance in accordance with FDA rules and regulations. OxyHealth has been formally cleared according to the April, 8 2014 FDA Close Out Letter.
FDA 510(k) Clearance #K001409 for all portable chambers
FDA 510(k) Clearance #K041007 for Fortius 420