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510(k) Data Aggregation
K Number
K221901Device Name
EleGARD
Manufacturer
Date Cleared
2022-07-29
(29 days)
Product Code
Regulation Number
880.6080Why did this record match?
Product Code :
FOA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EleGARD™ Patient Positioning System (EleGARD) is a cardiopulmonary board which may elevate a patient's head and thorax: including during airway management; during manual CPR, manual CPR adjuncts, CPR with the LUCAS® Chest Compression System or ARM XR Automated Chest Compressor; and patient transport. EleGARD is indicated for adults only when used with the LUCAS Chest Compression System or the ARM XR Automated Chest Compressor. When not used with an automated compression system, EleGARD can be used for adults and children, not including infants and neonates.
Device Description
The EleGARD™ patient positioning system is an electrically powered device on which a patient is placed. It can be used to elevate a patient's head and thorax during a number of different procedures, e.g., airway management and different CPR techniques.
The EleGARD™ acts as a back board for airway management and for performing CPR. It allows the user to position the patient in supine or with the head and thorax elevated. The EleGARD™ is a cardiopulmonary back board which is placed under the patient.
There are several different CPR methods which use a back board, stretcher or bed, e.g., manual CPR, manual CPR Adjuncts, and with the Defibtech Chest Compression System and ARM XR backplate or with the LUCAS Chest Compression System as previously cleared under K191689.
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K Number
K191689Device Name
EleGARD Patient Positioning System
Date Cleared
2020-02-13
(233 days)
Regulation Number
880.6080Why did this record match?
Product Code :
FOA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EleGARD™ Patient Positioning System is cardiopulmonary board which may elevate a patient's head and thorax including during airway management; during manual CPR, manual CPR adjuncts, CPR with the LUCAS Chest Compression Systems; and patient transport.
Device Description
The EleGARD™ patient positioning system is an electrically powered device on which a patient is placed. It can be used to elevate a patient's head and thorax during a number of different procedures, e.g., airway management and different CPR techniques.
The EleGARD™ acts as a back board for airway management and for performing CPR. It allows the user to position the patient in supine or with the head and thorax elevated. The EleGARD™ is a cardiopulmonary back board which is placed under the patient.
It may be used with the patient lying flat or may elevate the patient's thorax and head. The device would be used in emergency conditions when healthcare professionals need to: provide airway management, perform CPR with manual / hand compressions, adjunctive manual CPR devices, and a LUCAS mechanical compression device, perform manual bag / mask ventilation, and transport a patient.
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