HyperbaricsRx - Hyperbaric Chambers and HBOT Information

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Hyperbaric Chambers are Class II Medical Devices in the United Stats of America regulated by the Food and Drug Administration (FDA).  As indicated in their corresponding FDA 510(K) clearance, these chambers including but not limited to steel hyperbaric chambers, also commonly referred to as "Hard Chambers" and portable hyperbaric chambers, also commonly referred to as "Soft Chambers" or "Mild Hyperbaric Chambers" are prescription devices.  FDA regulations require that hyperbaric chambers be sold to, or on the order of a state licensed practitioner.

FDA 510K Cleared Portable Hyperbaric Chambers are cleared for the treatment of oxygen deficiency due to Acute Altitude Sickness (also known as AMS). FDA 510K Cleared Hard Chambers are cleared for the treatment of the 13 Undersea and Hyperbaric Medical Society (UHMS) approved indications, which are:

1.    Air or Gas Embolism

2.    Carbon Monoxide Poisoning, Carbon Monoxide Poisoning Complicated By Cyanide Poisoning

3.    Clostridial Myositis and Myonecrosis (Gas Gangrene)

4.    Crush Injury, Compartment Syndrome and Other Acute Traumatic Ischemias

5.    Decompression Sickness

6.    Arterial Insufficiencies: Enhancement of Healing In Selected Problem Wounds

7.    Severe Anemia

8.    Intracranial Abscess

9.    Necrotizing Soft Tissue Infections

10.  Osteomyelitis (Refractory)

11.  Delayed Radiation Injury (Soft Tissue and Bony Necrosis)

12.  Compromised Grafts and Flaps

13.  Acute Thermal Burn Injury

HyperbaricsRx is an authorized reseller, training facility and/or service facility for a variety of products, we are not equipment manufacturers.  For specific product manufacturer information and to view corresponding 510K Clearances see www.fda.gov .  For information on UHMS approved indications see www.uhms.org .