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510(k) Data Aggregation
K Number
K061023Device Name
THERMOSUIT SYSTEM
Manufacturer
LIFE RECOVERY SYSTEMS HD, LLC
Date Cleared
2006-09-20
(160 days)
Product Code
NZE
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
LIFE RECOVERY SYSTEMS HD, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ThermoSuit System™ is a thermal requlating system.
Indications for Use are
a. Temperature reduction in patients where clinically
indicated, e.g. in hyperthermic patients;
b. Monitoring of patient temperature.
Device Description
The ThermoSuit System (TSS) is a device that allows rapid patient cooling by the circulation of cold water in direct contact with the skin of the patient. Patient temperature measurements control the extent and duration of cooling, by controlling pump output and drainage of cooling fluid. Temperature measurements and associated alarm signals are designed to prevent overcooling.
The ThermoSuit System™ consists of the following main components:
- . ThermoSuit Body Enclosure
- Multi-lumen Umbilicus Hose .
- . Reservoir/Pump Assembly
- . Pump Controller Console
- . Other Components
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