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510(k) Data Aggregation

    K Number
    K221700
    Device Name
    AutoPulse NXT Resuscitation System
    Manufacturer
    ZOLL Circulation, Inc.
    Date Cleared
    2023-03-09

    (269 days)

    Product Code
    DRM
    Regulation Number
    870.5200
    Why did this record match?
    Product Code :

    DRM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AutoPulse NXT Resuscitation System is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by a lack of spontaneous breathing and pulse. The AutoPulse NXT System must be used only in cases where chest compressions are likely to help the patient. The AutoPulse NXT System 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 AutoPulse® NXT Resuscitation System (also referred to as the AutoPulse® Model 200 or AP 200 System) is an automatic, portable, battery-powered chest compressor, which provides chest compressions as an adjunct to performing manual cardiopulmonary resuscitation (CPR). The system can adjust to different patient sizes and can operate in environments with limited space, such as moving vehicles. The system may be a reasonable alternative to conventional CPR in specific settings where the delivery of high-quality manual compressions may be challenging or dangerous for the provider (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). The AutoPulse® NXT Resuscitation System (hereinafter referred to as AutoPulse® NXT System) consists of four (4) primary components: a reusable platform (AutoPulse® NXT Platform), a single-use chest compression assembly (AutoPulse® NXT Band), a rechargeable battery (AutoPulse® NXT Battery), and a reusable battery charger (AutoPulse® NXT Battery Charger). The AutoPulse® NXT Platform contains the mechanical drive mechanism, control system, software, and electronics necessary to generate and control the motion required to perform mechanical chest compressions. User controls and indicators are contained in two (2) identical User Control Panels provided for ease-of-use. The AutoPulse® NXT Band is a chest compression assembly which consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. Attached to the AutoPulse® NXT Platform, the NXT Band is automatically adjusted to the patient and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. The band is a single-use component that is attached to the AutoPulse® NXT Platform before each use. The Lithium-ion (Li-ion) Battery is a removable component that supplies power for operation of the AutoPulse® NXT Platform. It also includes a printed circuit assembly to provide "smart battery" features including cell balancing, state of charge (SOC) reporting, a history archive, and safety circuits. The AutoPulse® NXT Battery Charger is a reusable, stand-alone unit intended to charge and test-cycle AutoPulse® NXT Batteries. The battery charger has two (2) charging bays, each with its own indicators, and is used to charge and test-cycle up to two (2) AutoPulse® NXT batteries simultaneously. When in use, the battery charger continuously tests itself and any compatible batteries in its ways. The AutoPulse® NXT System comprises the subject devices included in this 510(k).
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    K Number
    K211289
    Device Name
    RMU-2000 Automated Chest Compression System
    Manufacturer
    Defibtech, LLC
    Date Cleared
    2021-11-09

    (195 days)

    Product Code
    DRM
    Regulation Number
    870.5200
    Why did this record match?
    Product Code :

    DRM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RMU-2000 Automated Chest Compression System (ACC) 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. The RMU-2000 must only be used in cases where chest compressions are likely to help the patient. The RMU-2000 ACC is intended for use as an adjunct to manual cardiopulmonary resuscitation (CPR) on adult patients 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 personnel are available to provide effective CPR).
    Device Description
    The RMU-2000 Automated Chest Compression (ACC) System is an automated, portable, battery-powered device that provides chest compressions on adult patients who have cardiac arrest. The RMU-2000 ACC, when applied to a patient who is unconscious and not breathing, is designed to: · Provide consistent depth and rate chest compressions. • Allow for automated chest compressions in both the in-hospital and out of hospital settings, including during patient transport. - Be applied to the patient with minimal interruption of CPR. The major components of the RMU-2000 ACC are the Backboard, the Frame and the Compression Module. The Backboard is placed under the patient to provide a base for the ACC system. After a single-use Suction Cup is pre-installed onto the Frame, the Compression Module is then mounted into the Frame, causing the Suction Cup to attach to the Compression Module's piston drive. The Compression Module and Frame assembly is then placed over the patient and snaps into the Backboard with self-locking latches. The Compression Module contains the user interface, a replaceable Battery Pack, and the piston drive and is used to generate the chest compressions. The RMU-2000 ACC can be operated using a replaceable, rechargeable Battery Pack or with an external power adapter used in conjunction with the battery. A fully-charged, new Battery Pack can provide continuous operation for at least an hour and can be recharged in the Compression Module. Once the RMU-2000 ACC has been powered on and applied to the patient, compressions are initiated by adjusting the piston to the patient's chest and pressing either of the Run Compressions buttons. Additional user interface features include a pause function, a warning indicator to notify the operator for possible misuse or malfunction, and a Battery Pack capacity gauge. A Bluetooth® technology ON/OFF button on the user control panel allows the Compression Module to be wirelessly connected to a personal computer and for ACC data retrieval and event reporting when used in conjunction with utility software available at www.defibtech.com. A USB port on the underside of the Compression Module also allows connection to a personal computer when a wired connection is preferred or when a Bluetooth® connectivity is not possible or desired.
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    K Number
    K173553
    Device Name
    LUCAS 3 Chest Compression System
    Manufacturer
    Jolife AB
    Date Cleared
    2018-02-08

    (84 days)

    Product Code
    DRM
    Regulation Number
    870.5200
    Why did this record match?
    Product Code :

    DRM

    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.
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    K Number
    K161768
    Device Name
    LUCAS 3 Chest Compression System
    Manufacturer
    Jolife AB
    Date Cleared
    2016-11-09

    (135 days)

    Product Code
    DRM
    Regulation Number
    870.5200
    Why did this record match?
    Product Code :

    DRM

    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.
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    K Number
    K153628
    Device Name
    ROSC-U Mini Chest Compressor (RMCC)
    Manufacturer
    Resuscitation International, LLC
    Date Cleared
    2016-01-30

    (43 days)

    Product Code
    DRM
    Regulation Number
    870.5200
    Why did this record match?
    Product Code :

    DRM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
    Device Description
    The RMCC is an automated, portable chest compressor, which provides continuous chest compressions as an adjunct to performing manual CPR. It is powered by a battery powered Control Unit. The RMCC provides consistent CPR support for cardiac arrest patients under conditions which might otherwise hinder the effectiveness of manual techniques. - 1. Compressor Assembly: contains a motor that drives the compressor pad to depress a patient's chest. - 2. Control Unit: contains the battery, power ON/OFF switch, Function Control Panel and umbilical power cord connecting it to the compressor assembly. Note: The battery charger is a separate unit. - 3. Torso Restraint: is placed underneath and around the back of the patient to firmly secure the compressor assembly to the patient. - 4. Stabilizer: serves a dual purpose; providing a head support and also attaches to the torso restraint to provide stability during continuous operation of the RMCC especially during patient transport.
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    K Number
    K141809
    Device Name
    RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
    Manufacturer
    DEFIBTECH, LLC
    Date Cleared
    2014-10-27

    (112 days)

    Product Code
    DRM
    Regulation Number
    870.5200
    Why did this record match?
    Product Code :

    DRM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RMU-1000 ACC is intended for use as an adjunct to manual cardiopulmonary resuscitation (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 personnel are available to provide effective CPR).
    Device Description
    The RMU-1000 Automated Chest Compression (ACC) System is an automated, portable, battery-powered device that provides chest compressions on adult patients who have cardiac arrest. The RMU-1000 ACC, when applied to a patient who is unconscious and not breathing, is designed to: - Provide consistent depth and rate chest compressions. - Allow for automated chest compressions in both the in-hospital and out of hospital settings, including during patient transport. - Be applied to the patient with minimal interruption of CPR. The major elements of the RMU-1000 ACC are the Backboard, Frame and Compression Module. The Backboard is placed under the patient to provide a base for the RMU-1000 ACC system. The Frame is placed over the patient and snaps into the Backboard with two self-locking latches, one on each side of the Frame. The Compression Module mounts into the Frame and contains the user interface, the replaceable lithium ion battery and the piston drive (and motor) used to generate the chest compressions. A replaceable, single-use Patient Interface Pad at the distal end of the Piston contacts the patient's chest and serves to soften the edges of the Piston during compressions. Compression rate and depth, performed according to current American Heart Association (AHA) and other internationally-recognized resuscitation guidelines, are initiated using a simple three-step operational sequence once the RMU-1000 ACC has been applied to a patient: - the Compression Module is turned on by pressing the power button; - the Piston height adjusted for the patient's chest size by pressing the appropriate height adjust button; and - the appropriate compressions button pushed (either continuous compressions or an automatic pause for breaths). Additional user interface features include a compression pause function button, service warning indicator, warning mute button, and battery capacity gauge. The RMU-1000 ACC can be operated using a replaceable, rechargeable lithium-ion battery pack or with an external power supply. A fully-charged, new battery can provide continuous operation for over an hour and can be recharged while in the Compression Module. A USB port on the Compression Module allows maintenance functions to be performed (outside of emergency use) through a connection to a personal computer. The RMU-1000 ACC fits in a carry case that holds all the various System elements and accessories, spares (optional) and labeling.
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    K Number
    K112998
    Device Name
    AUTOPULSE RESUSCITATION SYSTEM MODEL 1000
    Manufacturer
    ZOLL CIRCULATION
    Date Cleared
    2012-03-15

    (160 days)

    Product Code
    DRM
    Regulation Number
    870.5200
    Why did this record match?
    Product Code :

    DRM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
    Device Description
    The AutoPulse Resuscitation System Model 100 is an automated, portable, batterv powered device that compresses the chest of an adult human as an adjunct to manual CPR. The AutoPulse System consists of 4 primary components, a reusable Platform, a single use chest compression assembly (LifeBand), a rechargeable battery, and a battery charger. The AutoPulse Platform contains the mechanical drive mechanism, control system, software and electronics necessary to generate and control the force required to perform mechanical chest compressions. User controls and indicators are contained in the User Control Panel. The AutoPulse Platform and LifeBand are unchanged. A new battery and battery charger are the subject devices of this 510(k).
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    K Number
    K102068
    Device Name
    MINIATURIZE CHEST COMPRESSOR (MCC)
    Manufacturer
    RESUSCITATION INTERNATIONAL
    Date Cleared
    2010-11-16

    (116 days)

    Product Code
    DRM
    Regulation Number
    870.5200
    Why did this record match?
    Product Code :

    DRM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
    Device Description
    The miniaturized compressor (MCC) is an automated, portable chest compressor, which provides continuous chest compressions as an adjunct to performing manual CPR. It is powered by compressed oxygen or air. The MCC provides consistent CPR support for cardiac arrest patients under conditions, which might otherwise hinder the effectiveness of manual techniques.
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    K Number
    K090422
    Device Name
    LUCAS 2
    Manufacturer
    JOLIFE AB
    Date Cleared
    2009-06-17

    (119 days)

    Product Code
    DRM
    Regulation Number
    870.5200
    Why did this record match?
    Product Code :

    DRM

    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.
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    K Number
    K072527
    Device Name
    AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
    Manufacturer
    ZOLL CIRCULATION
    Date Cleared
    2008-03-19

    (194 days)

    Product Code
    DRM
    Regulation Number
    870.5200
    Why did this record match?
    Product Code :

    DRM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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