Search Results
Found 5 results
510(k) Data Aggregation
K Number
K173553Device Name
LUCAS 3 Chest Compression System
Manufacturer
Jolife AB
Date Cleared
2018-02-08
(84 days)
Product Code
DRM
Regulation Number
870.5200Why did this record match?
Applicant Name (Manufacturer) :
Jolife AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LUCAS Chest Compression System is to be used for performing external cardiac compressions on adult Patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
LUCAS must only be used in cases where chest compressions are likely to help the patient.
The LUCAS device is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/ consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).
Device Description
The LUCAS Chest Compression System is a portable tool designed to overcome problems identified with manual chest compressions. The LUCAS device assists rescuers by delivering effective, consistent and continuous chest compressions as recommended in the American Heart Association guidelines and the European Resuscitation Council guidelines.
The LUCAS Chest Compression System can be used in a wide variety of situations and settings; on the scene, during patient movement, during transportation in road and air ambulances, in hospitals and catheterization laboratories.
The main parts of the LUCAS Chest Compression System include:
- . A Back Plate which is positioned underneath the patient as a support for the external chest compressions.
- . An Upper Part which contains the proprietary and rechargeable LUCAS Battery and the compression mechanism with the disposable Suction Cup.
- . A Stabilization Strap which helps to secure the position of the device in relation to the patient.
- . A Carrying Case.
In addition the following optional Accessories are offered as part of the system:
- LUCAS Battery, Dark Grey .
- . LUCAS Power Supply
- . LUCAS Car Power Cable, 12-28VDC
- . LUCAS PCI Back Plate
- o LUCAS Battery Charger
- o LUCAS Anti Slip, Slim Back Plate
- . LUCAS Trolley
The LUCAS 3 version 3.1 is the same device as the cleared LUCAS 3 device (K161768) with exception of the option to change device factory default settings according to local protocols. LUCAS 3 version 3.1 in its factory default settings has identical performance characteristics as the predicate device LUCAS 3.
Ask a Question
K Number
K161768Device Name
LUCAS 3 Chest Compression System
Manufacturer
Jolife AB
Date Cleared
2016-11-09
(135 days)
Product Code
DRM
Regulation Number
870.5200Why did this record match?
Applicant Name (Manufacturer) :
Jolife AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LUCAS Chest Compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
LUCAS must only be used in cases where chest compressions are likely to help the patient.
The LUCAS device is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).
Device Description
The LUCAS 3 Chest Compression System is a portable tool designed to serve as an adjunct to manual chest compressions. The LUCAS device assists rescuers by delivering effective, consistent and continuous chest compressions as recommended in the American Heart Association quidelines and the European Resuscitation Council quidelines.
The LUCAS chest compression system can be used in a wide variety of situations and settings; on the scene, during patient movement, during transportation in road and air ambulances, in hospitals and catheterization laboratories.
The device consists of the following components:
- . A Back Plate which is positioned underneath the patient as a support for the external chest compressions.
- An Upper Part which contains the proprietary and rechargeable LUCAS Battery and the ● compression mechanism with the disposable Suction Cup.
- A Stabilization Strap which helps to secure the position of the device in relation to the ● patient.
- A Carrying Case. ●
In addition the following optional Accessories are offered as part of the system:
- LUCAS Battery, Dark Grey ●
- LUCAS Power Supply
- LUCAS Car Power Cable, 12-28VDC ●
- LUCAS PCI Back Plate ●
- LUCAS Battery Charger ●
- LUCAS Anti Slip, Slim Back Plate
- o LUCAS Trolley
The LUCAS 3 CHEST COMPRESSION SYSTEM captures data for post event review which may be transmitted locally using Bluetooth (transmission only available when device is powered OFF).
LUCAS 3 has substantially the same performance characteristics as the predicate device LUCAS 2.
Ask a Question
K Number
K090422Device Name
LUCAS 2
Manufacturer
JOLIFE AB
Date Cleared
2009-06-17
(119 days)
Product Code
DRM
Regulation Number
870.5200Why did this record match?
Applicant Name (Manufacturer) :
JOLIFE AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LUCAS 2 Chest Compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness. LUCAS 2 must only be used in cases where chest compressions are likely to help the patient.
Device Description
LUCAS 2 is an electrically powered mechanical chest compression system providing controlled automated chest compressions on adult patients who have acute circulatory arrest. LUCAS 2 consists of an upper part containing the electrically driven piston rod, which acts on the patients chest via a pressure pad. The pressure pad is surrounded by a suction cup. The support legs of the upper part are fastened to the back plate prior to starting compressions.
Ask a Question
K Number
K062401Device Name
MODIFICATION TO LUCAS
Manufacturer
JOLIFE AB
Date Cleared
2006-09-28
(43 days)
Product Code
DRM
Regulation Number
870.5200Why did this record match?
Applicant Name (Manufacturer) :
JOLIFE AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LUCAS® External Cardiac Compressor is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.
LUCAS® must only be used in cases where manual chest compression would be used.
LUCAS® is only intended for temporary use.
Device Description
LUCAS® is a pneumatically powered mechanical chest compression system providing controlled automated chest compressions on adult patients who have acute circulatory arrest.
LUCAS® consists of an upper part containing a pneumatically driven piston rod, which acts on the patients chest via a pressure pad integrated into the suction cup.
The support legs of the upper part are fastened to the back plate prior to starting compressions.
LUCAS® is powered by compressed air from a wall outlet in a hospital or an ambulance, or from a cylinder.
Ask a Question
K Number
K053403Device Name
LUCAS
Manufacturer
JOLIFE AB
Date Cleared
2006-02-01
(57 days)
Product Code
DRM
Regulation Number
870.5200Why did this record match?
Applicant Name (Manufacturer) :
JOLIFE AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LUCAS® External Cardiac Compressor is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontancous breathing and pulse, and loss of consciousness.
LUCAS® can be used in cases where manual chest compression would be used.
LUCAS® is only intended for temporary use.
Device Description
LUCAS is a pneumatically powered mechanical chest compression system providing controlled automated chest compressions on adult patients who have acute circulatory arrest.
LUCAS consists of an upper part containing a pneumatically driven piston rod, which acts on the patient's chest via a pressure pad. The pressure pad is surrounded by a suction cup.
The support legs of the upper part are fastened to the back plate prior to starting compressions.
LUCAS can be powered by oxygen or air from a wall outlet in a hospital or an ambulance, or from a cylinder.
LUCAS is designed to provide:
- · Consistent and uninterrupted compressions according to the guidelines given by American Heart Association (AHA);
- · Good circulation during the patient transport process;
- · Safety during transportation for both emergency medical personnel and patient, allowing emergency medical personnel to wear safety belts during transportation while LUCAS delivers continuous, consistent and uninterrupted compressions;
- · Hands-free compressions in any situation.
LUCAS can be applied to the patient in less than 20 seconds.
Ask a Question
Page 1 of 1