(468 days)
The conditions listed as appropriate for the Hyperbaric Oxygen Therapy in the current edition of Undersea and Hyperbaric Medical Society (UHMS) Hyperbaric Oxygen Therapy Committee Report (1999) are as follows:
- Air or Gas Embolism .
Carbon Monoxide Poisoning and Carbon Monoxide Poisoning complicated by Cyanide Poisoning - Clostridial 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 and Flaps (Compromised) .
- Thermal Burns .
Monoplace Hyperbaric Chamber
This document is a 510(k) premarket notification approval letter for the ATA HCM Monoplace Hyperbaric System. It formally approves the device for marketing based on its substantial equivalence to a legally marketed predicate device.
The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it is an administrative letter confirming that the device can be legally marketed.
Therefore, I cannot fulfill your request for information on acceptance criteria and studies from the provided text. The document is solely a regulatory approval, not a technical report detailing performance metrics or testing results.
§ 868.5470 Hyperbaric chamber.
(a)
Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).(b)
Classification. Class II (performance standards).