FDA Statement and Legal Notice
OxyHealth LLC maintains full FDA compliance for all hyperbaric chamber products. Our commitment to regulatory excellence ensures the highest standards of safety and efficacy for every device we manufacture.
Regulatory Status
FDA-Cleared Class 2 Medical Devices
All OxyHealth hyperbaric chambers are classified as Class 2 medical devices requiring a physician prescription. Our chambers are approved for both clinical and home use through FDA 510(k) clearance.
What This Means for You
- Class 2 Medical Device - OxyHealth chambers have been evaluated and cleared by the FDA for safe clinical use, meeting engineering and safety standards under U.S. law.
- Physician Prescription Required - A physician prescription is required to purchase an OxyHealth hyperbaric chamber, ensuring proper medical oversight.
- Approved for Clinical and Home Use - FDA 510(k) clearance authorizes OxyHealth chambers for use in clinical settings as well as private residences.
Approved Indications
13 FDA-Approved HBOT Indications
The U.S. Food and Drug Administration has approved hyperbaric oxygen therapy for the following 13 medical conditions.
Air or Gas Embolism
Acute Carbon Monoxide Poisoning
Gas Gangrene
Crush Injury
Decompression Sickness
Enhancement of Healing in Selected Problem Wounds
Exceptional Blood Loss (Anemia)
Intracranial Abscess
Necrotizing Soft Tissue Infections
Osteomyelitis
Delayed Radiation Injury
Compromised Skin Grafts & Flaps
Thermal Burns
Compliance Record
Key Regulatory Points
OxyHealth maintains an exemplary record of FDA compliance and regulatory adherence, backed by decades of commitment to safety and transparency.
State Licensed Practitioner Requirement
OxyHealth hyperbaric chambers must be sold to or on the order of a state licensed practitioner, ensuring proper medical oversight for every device placed into service.
FDA 510(k) Clearance Since Inception
OxyHealth has maintained FDA 510(k) clearance since the company was founded, demonstrating a continuous commitment to meeting federal regulatory standards for medical devices.
CFG Licenses for Domestic and International Sales
OxyHealth holds Certificate to Foreign Goods (CFG) licenses, authorizing the company to sell its hyperbaric chambers both domestically within the United States and internationally.
Clean FDA Compliance Record
There are no open complaints or items that need corrective actions per the FDA. OxyHealth maintains a clean regulatory record with no outstanding issues.
April 8, 2014 FDA Close-Out Letter
The April 8, 2014 FDA close-out letter formally cleared all inquiries, confirming that OxyHealth has satisfied all FDA questions and requirements.
Documentation
Available Regulatory Documents
The following regulatory documents are available upon request. Contact our team to obtain copies for your records.
April 8, 2014 FDA Close Out Letter
Official FDA close-out letter confirming all inquiries have been formally cleared and resolved.
Available upon request
510(k) Clearance for Solace210, Respiro270, Vitaeris320, Quamvis320
FDA 510(k) clearance documentation covering the Solace210, Respiro270, Vitaeris320, and Quamvis320 soft chamber models.
Available upon request
510(k) Clearance #K041007 for Fortius 420
FDA 510(k) clearance documentation specific to the Fortius 420 hard shell hyperbaric chamber.
Available upon request
CFG License for Fortius 420
Certificate to Foreign Goods license authorizing international distribution of the Fortius 420.
Available upon request
CFG License for Soft Chambers
Certificate to Foreign Goods license authorizing international distribution of OxyHealth soft hyperbaric chambers.
Available upon request
Need Regulatory Documentation?
Our team can provide copies of all FDA clearance letters, 510(k) documentation, and CFG licenses. Contact us for any regulatory or compliance questions.