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510(k) Data Aggregation
K Number
K003368Device Name
ACROTHERM
Manufacturer
AQUARIUS MEDICAL CORP.
Date Cleared
2001-01-19
(81 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
AQUARIUS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K970367Device Name
THERMO-STAT SYSTEM
Manufacturer
AQUARIUS MEDICAL CORP.
Date Cleared
1997-12-17
(320 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
AQUARIUS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Thermo-STAT is designed to non-invasively treat hypothermic patients by rewarming their body core. This is accomplished with local application of negative pressure and a thermal load (heat) to a distal appendage.
Device Description
The Thermo-STAT is a non-invasive and portable body core warming device which provides a noninvasive technique to treat and prevent hypothermia. The Thermo-STAT's principle of action for counteracting hypothermia is to create a thermal pipeline between the skin and the body core. The Thermo-STAT functions by applying a combination of heat and pressure to only the distal aspect of an arm or leg. Using the Thermo-STAT, a thermal load is exchanged between the application site and the body core. Vasoconstriction in a hypothermic individual prevents superficial heat alone from effectively altering the body core temperature. The Thermo-STAT circumvents this "vasoconstrictive blockade" with a slight negative pressure (40-60mmHg) and enables a thermal load to be transferred directly and exclusively from a thermal heat pad to the body core via the bloodstream. Current means, such as forced air rewarming, fail to effectively overcome the "vasoconstrictive blockade."
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