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510(k) Data Aggregation
K Number
K101262Device Name
FLEXI-LITE
Manufacturer
PRESSURE-TECH, INC.
Date Cleared
2010-06-10
(36 days)
Product Code
CBF
Regulation Number
868.5470Why did this record match?
Applicant Name (Manufacturer) :
PRESSURE-TECH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexi-Lite Hyperbaric chamber is a 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. Caution: Federal law restricts this device to sale by or on the order of a physician.
Device Description
The Flexi-Lite flexible hyperbaric chamber is a mild hyperbaric chamber for pressures less than 4 psi. This lightweight and portable chamber utilizes atmospheric Air as supplied by a GAST model 0523/1023 "oil-less, breathable air compressor" to pressurize the chamber and provide a suitable environment for the occupant. The Flexi-Lite construction utilizes a dual bag design with the inner the ooonpining the pressure and an exterior bag to provide structural support. All components are attached to the inner bag utilizing bulkhead connections. It is outfitted with two externally mounted metal relief valves (set at 4 psi), 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).
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