(141 days)
To provide mild hyperbaria for the treatment of Acute Mountain Sickness (AMS) and its associated mild symptoms. The Flexi-Lite Hyperbaric chamber is a rugged & portable hyperbaric chamber intended to be used in treating mild symptoms consistent with Acute Mountain Sickness (AMS) as prescribed by or under the direction of a physician.
The Flexi-Lite flexible hyperbaric chamber is a mild hyperbaric chamber for pressures less than 5 psi. This lightweight and portable chamber utilizes atmospheric Air as supplied by a GAST model 0523 "oiless, breathable air compressor" to pressurize the chapplice und provide a suitable environment for the occupant. The Flexi-Lite construction utilizes and bag design with the inner bag containing the pressure and an exterior hag to provide structural support. All components are attached to the inner bag utilizing oulkhead connections. It is outfitted with two externally mounted metal relief valves (set out nedit two metal Air addition valves (one external & one internal), two metal depressurization valves (one external & one internal), two pressure gauges (one external & one internal, and one metal Air sampling port. In total it weighs 39 lbs (compressor adds another 54 lbs).
This document is a 510(k) premarket notification for the Flexi-Lite Hyperbaric Chamber, seeking to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe acceptance criteria for a study demonstrating device performance, nor does it present results from such a study.
Instead, the submission focuses on comparing the new device's attributes, intended use, and specifications to existing, predicate hyperbaric chambers to argue for substantial equivalence. The FDA letter confirms the determination of substantial equivalence based on the provided information, allowing the device to be marketed.
Therefore, I cannot provide the requested information about acceptance criteria and study results because this type of information is not present in the provided text. The document is a regulatory submission for market clearance, not a clinical or performance study report.
§ 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).