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The HeartCheck™ Cardi Beat ECG Monitor device with the GEMS Mobile software is an over-the-counter device to be used by patients 21 years of age or older. It is intended to record, store and transfer single channel Heart Rhythm signals and display Heart Rhythm waveforms. This 1-lead cardiac monitor allows remote users to display and transmit their ECG data to medical professionals via a communication device to a remote server. The HeartCheck™ Cardi Beat ECG Monitor combined with GEMS Mobile software is indicated for users who are concerned about their heart rhythms and may have experienced symptoms that may suggest irregular or abnormal heart rhythms. Symptoms may include: - · Skipped beats - · Palpitations - · Racing heart - Fainting and lightheadedness - · Irregular rate - · History of any related heart abnormalities The HeartCheck™ Cardi Beat ECG Monitor along with the GEMS Mobile software is not intended to substitute a hospital diagnostic ECG device. Users with an implanted pacemaker or are not recommended to use this device while the implanted device is operational. Users where their pacemaker is operational will not be able to record their ECG under normal sinus rhythm with the pacemaker on.

The HeartCheck™ CardiBeat ECG Monitor device model HC-WE-01 is an ambulatory and telemedicine based solution that is intended to enable uses to record, store, transfer, and display single channel ECG waveforms. The HeartCheck™ CardiBeat ECG Monitor combined with GEMS™ Mobile enables the user to send their ECG recordings to a medical service for review and interpretation by a qualified health service professional, such as a physician. The 1 lead ECG Event Monitor is specifically designed to operate with GEMS™ Mobile software, a smartphone software configured to run on mobile devices such as smartphones and tablets. The device will record a pre-selected amount of user ECG activity, as directed by the user. Typical configuration is to record 30 seconds of ECG per event. The HeartCheck™ CardiBeat ECG Monitor is activated through touch by the user whenever a recording is needed. The recorded data serves as a reliable heart rhythm record that may later be shown to physicians or other health care professionals for confirmation of the presence or absence of an arrhythmia. When a user feels that a cardiac event is occurring, the utilization of the HeartCheck™ CardiBeat ECG Monitor with GEMS™ Mobile has the feature of recording this real time data that would otherwise not be possible to capture. While performing the recording, data is continuously sent to the smartphone or tablet by secure Bluetooth connection technology. Following an initial physician review, the ECG can be displayed for quality and observation purposes on the GEMS™ Mobile application. Users will not be able to view the waveform without a physician's pre-review from the SMART Monitoring system. This system used the HeartCheck™ ECG PEN and GEMS™ Home system (K11159) with an ECG reading service as a predicate device. The recorded data can be stored locally on the mobile device and/or not transmitted to CardioComm Solutions, Inc.'s SMART Monitoring ECG reading service (powered by GlobalCardio™ K111320) for analysis and assessment by qualified professionals.

Guava II is intended to be used by cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multilead ECG devices. Guava II is intended to be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems. Guava II includes an algorithm that will analyze the 12 Lead ECG and produce measurements of the ECG recording as well as textual interpretation. The product also includes an automatic analysis and interpretation software library that provides ECG signal processing and analysis on a beat by beat basis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for up to twelve (12) leads of historic ambulatory ECG data. The Guava II algorithm analysis can detect and classify arrhythmias and may be used to triage data, however, Guava II is not intended to offer independent diagnosis or provide medical alarms. Clinical judgment and experience are used to check and interpret the data as part of a diagnosis. Guava II is not for use in lifesupporting or sustaining systems or EGG monitoring devices. Guava II is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate.

The Guava II is a medical device software with a formal Application Programming Interface (API). The API can be invoked from Host Applications to provide services for capturing, storing, retrieving, viewing, editing, and analyzing ECGs (1-, 2-, 3-Channel and 12-Lead) and other Biosignals. Guava II may also be licensed to 3rd party organizations interested in embedding the capabilities within their own products. When the Guava II is used in other medical products, manufacturers will identify the indications for use depending on the application of their device. The Guava II is not a life-supporting or life-sustaining system. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.

The Tablet Commander device is for use by patients to collect and transmit general health information, physiological measurements and other data between themselves and a caregiver. The Tablet Commander makes no diagnosis. Clinical judgment and experience are required to check and interpret the information transmitted. The Tablet Commander is not intended as a substitute for medical care.

The Tablet Commander is a software application. Once installed on a commercially-available device, the Tablet Commander software uses standard communication protocols to exchange information with other medical devices (peripherals). Data collected from the medical devices is transmitted back to a database for review by a caregiver. The Tablet Commander software has a user interface which allows the patient and caregiver to communicate using methods which include questions and answers.

GlobalCardio is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multilead ECG devices. GlobalCardio includes a QRS Algorithm that will analyze the 12 Lead ECG and produce measurements of the ECG recording as well as textual interpretation. GlobalCardio will be accessed over the Internet and data will be stored at either the client site or at the central GlobalCardio data warehouse. Data will be secure, and with separate data stores for each client. Users will be able to access specific modules for managing patient cardiac related data such as arrhythmia data that fit their patients' needs. GlobalCardio is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate. GlobalCardio does not offer diagnosis or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.

GlobalCardio is a cardiology software product, delivered over the web using the Application Service Provider (ASP) model. GlobalCardio operates on IBM compatible PCs and runs within an Internet browser, Microsoft Internet Explorer. GlobalCardio operates as a client server application. GlobalCardio presents an interface for health care professionals to input, store, query and output data from a centrally hosted, or client based relational database. The product is a web-based database system for the secure storage of all aspects of a patient's cardiology record including: arrhythmia follow-up and diagnosis, transtelephonic pacemaker follow-up, implantable cardioverter defibrillator (ICD) follow-up, in-clinic follow-up, 12 Lead ECG testing, cardiac rehabilitation data, stress test data pathological diagnosis, ECGs, ECG information, clinical history, physician notes, clinical history and associated reports and queries. GlobalCardio is a comprehensive ECG management system. GlobalCardio is sold in two ways: - Per-use or fee-for-service. Software is not shipped and installed, but instead customer accounts are set up for access and record management from the centrally hosted web application. Login IDs and passwords are created for each authorized client. Databases reside in the secure, firewall protected, warehouse at the application host site. - Technology licensing. GlobalCardio technology is licensed to another company which then hosts a complete service, as described above, including secure data warehousing. All activity on GlobalCardio is recorded by User ID. User IDs are provided for each customer to access their own secure database(s). GlobalCardio is designed as a multi-user system capable of supporting large volumes of simultaneous users. Data can be entered via keyboard, mouse, bar code reader, sound card, serial port, or IrDA port, and stored to and retrieved from any computer media. Information can be displayed on the computer monitor or printed. GlobalCardio is not a life-supporting or life-sustaining system. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data. The purpose of this submission is to include the 12 Lead ECG and Digital Device Integration modules.

The Commander III is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.

The Commander III is an FDA cleared device (K053303, K053304). It is similar to a simple personal computer with a modem that stores and transmits data to remote locations. The Commander III is cleared for use with a pulse oximeter, a weight scale, a glucose meter, a peak flow meter and a blood pressure cuff. This premarket submission seeks to add an additional pulse oximeter, the PO100, for use with the Commander III. The PO100 is a reusable pulse oximeter that connects to the Cardiocom Commander III via a cable in the same manner as the currently cleared pulse oximeter.

The Commander III device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.

Commander III is similar to a simple personal computer with a modem that stores and transmits data. Commender III connects to a user's telephone line at home. It has a display that asks health related questions to which the user can respond 'Yes', 'No', or select from a list. It contains an integrated blood pressure meter. It also has inputs for devices such as weight scales, glucometers, peak flow meters and pulse oximeters. These devices download data through a RS232 connection. The functionality of these devices has not been modified; they are used as supplied from the manufacturer.

The Commander III device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site. Contraindications, Precautions and Warnings: The Commander III device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check and interpret the information transmitted. The Commander III is not intended as a substitute for medical care.

Commander III is similar to a simple personal computer with a modem that stores and transmits data. Commander III connects to a user's telephone line at home. It has a display that asks health related questions to which the user can respond 'Yes', 'No', or select from a list. It also has inputs for devices such as weight scales, blood pressure meters, glucometers, peak flow meters and pulse oximeters. These devices download data through a RS232 connection. The functionality of these devices has not been modified; they are used as supplied from the manufacturer.

The Commander II device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.

The Commander II is an automated device that connects to the user's telephone system at home. It has a display that asks the user health related questions and has inputs for devices such as weight scales, blood pressure meters, and other vital sign measurement devices.

GlobalCardio is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ECG technicians, nurses. monitoring service technicians, and other cardiac related institutions or care givers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices. GlobalCardio will be accessed over the Internet and data will be stored at either the client site or at the central GlobalCardio data warehouse. Data will be secure, and with separate data stores for each client. Users will be able to access specific modules for managing patient cardiac related data such as arrhythmia and implantable pulse generator (such as pacemakers, and implantable cardioverter defibrillators) data that fit their patients' needs. GlobalCardio is intended for use in clinics. hospitals, physician's offices, or anywhere a medical doctor deems appropriate. GlobalCardio does not offer diagnosis or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.

GlobalCardio is a cardiology software product, delivered over the web using the Application Service Provider (ASP) model. GlobalCardio operates on IBM compatible PCs and runs within an Internet browser, Microsoft Internet Explorer. GlobalCardio operates as a client server application. GlobalCardio presents an interface for health care professionals to input, store, query and output data from a centrally hosted, or client based relational database. The product is a web-based database system for the secure storage of all aspects of a patient's cardiology record including: arrhythmia follow-up and diagnosis, trans-telephonic pacemaker follow-up, implantable cardioverter defibrillator (ICD) follow-up, in-clinic follow-up, cardiac rehabilitation data, stress test data pathological diagnosis, ECGs, ECG information, clinical history, physician notes, clinical history and associated reports and queries. GlobalCardio is a comprehensive ECG management system. GlobalCardio is sold in two ways: Per-use or fee-for-service. Software is not shipped and installed, but instead . customer accounts are set up for access and record management from the centrally hosted web application. Login IDs and passwords are created for each authorized client. Databases reside in the secure, firewall protected, warehouse at the application host site. Technology licensing. GlobalCardio technology is licensed to another . company which then hosts a complete service, as described above, including secure data warehousing. All activity on GlobalCardio is recorded by User ID. User IDs are provided for each customer to access their own secure database(s). GlobalCardio is designed as a multi-user system capable of supporting large volumes of simultaneous users. Data can be entered via keyboard, mouse, bar code reader, sound card, serial port, or IrDA port, and stored to and retrieved from any computer media. Information can be displayed on the computer monitor or printed. GlobalCardio is not a life-supporting or life-sustaining system. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data.

GEMS is intended to be used as a data management tool for cardiologists, general practitioners, cardiac or ECG technicians, nurses, monitoring service technicians, and other cardiac related institutions or care qivers to store, retrieve, communicate and report ECG and ECG data acquired from a variety of ECG sources including single and multi-lead ECG devices, including diagnostic 12-lead devices. Users will be able to purchase specific modules for managing other patient cardiac related data such as pacemaker and rehabilitation data that fit their patients' needs. The ECG module may be licensed to other software developers as an ECG viewer for their products, GEMS is intended for use in clinics, hospitals, physician's offices, or anywhere a medical doctor deems appropriate, GEMS does not offer djagnosis or medical alarms. It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data. This version of GEMS includes the EASI algorithm for deriving an approximation to a 12-lead ECG from a 3-channel recording (using the lead placement specified in the EASITrak 12 Model 4100 / Zymed Model 4100 / EASI Arrhythmia Event Monitor user manual). If manual ST segment measurements will be made on the approximated 12-lead ECG, the patient population is limited to the following indications: Ages: 33 to 82 years Heights: 147 to 185 cm (58 to 73 in) Weights: 53 to 118 kg (117 to 261 lb) Height to Weight ratios: 1.41 to 2.99 cm/kq (0.25 to 0.54 in/lb)

GEMS is a software product designed for Microsoft Windows 98, Windows NT, and Windows 2000 operating systems running on an IBM compatible platform. GEMS is compatible with industry standard client server database management systems and as such will operate standalone or on a local or wide area networks. GEMS consists of a user interface that enables health care professionals to input, store, and output data from a relational database. The product consists of a set of modules that can be installed as required to customize the application to individual users' needs. Modular design has the benefit of encapsulating changes within the overall application. If a module changes, then in most cases the change will affect only that module and will not affect the rest of the program. This permits more efficient and controlled development and testing, and prevents new and unknown safety issues and anomalies from being introduced. This stability contributes to the safety and reliability of the product. GEMS is capable of multi-tasking and supports the linking and embedding of related information objects in the ECG. The software stores all aspects of a patient's cardiology record including: arrhythmia diagnosis, pathological diagnosis, ECGs, ECG information, physician notes, clinical history, pacemaker/ICD data and associated reports. Data can be entered via keyboard, mouse, bar code reader, serial port, or IrDA port, and stored to and retrieved from any computer media. Information can be displayed on the computer monitor or printed. GEMS is not a life-supporting or life-sustaining system, It is intended that competent human intervention be involved before any impact on health occurs. Clinical judgment and experience are used to check and interpret the data,