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510(k) Data Aggregation
K Number
K111745Device Name
KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER
Manufacturer
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
Date Cleared
2011-08-01
(41 days)
Product Code
DSH
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is indicated for diagnostic evaluation of patients who experience transient symptoms such as:
- . Dizziness
- Palpitations .
- . Syncope
- Chest pain .
Device Description
The KOH Express AF cardiac event recorder ("KOH" or "KOH Express AF" in short) is designed for the diagnostic evaluation of transient cardiac symptoms. The KOH is capable of storing up to 10 minutes of ECG recordings in solid state non-volatile memory. The device uses a two-wire lead set for single channel ECG acquisition. Using looping memory, the device captures ECG data; both before and after the patient experiences a cardiac symptom through auto-recording, or manually after the patient presses the RECORD button. ECG events are transmitted later in the form of an FM-modulated acoustic tone, when the SEND button is depressed. The device is configured in a compact sized case.
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K Number
K101703Device Name
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
Manufacturer
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
Date Cleared
2010-07-13
(26 days)
Product Code
DSI, DXH
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm, or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.
Device Description
CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center.
The chest-worn sensor is used for the acquisition, recording, and transmission of the ECG signal. The device is equipped with 4 electrodes on a harness and it houses a 3.6V AA battery, a Bluetooth transceiver and a buzzer.
The ECG signals are transmitted via Bluetooth to a handheld device with a proprietary interactive application, configured to process and transmit the ECG recordings. The handheld device is a mobile computing device with a display and a touch input such as a cell-phone. It has sufficient memory and processing capability to run the proprietary application.
When an arrhythmia event is detected the handheld device transmits the recorded ECG information automatically via cellular link, to the Monitoring Center or professional analysis. When cellular service is unavailable the patient has an option to transmit via a landline telephone.
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K Number
K101639Device Name
CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR
Manufacturer
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
Date Cleared
2010-06-25
(15 days)
Product Code
DSI, DXH
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CG-6108 ACT-1L Continuous ECG Monitor and Arrhythmia Detector are intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECC, automatically generates an alarm triggered by an arrhythmia detection algorithm, or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center.
The monitoring center provides the ECG data to the medical practitioner for evaluation.
Device Description
CG-6108 ACT-1L Continuous ECG Monitor and Arrhythmia Detector is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center.
The chest-worn sensor is used for the acquisition, recording, and transmission of the ECG signal. The device is equipped with 3 electrodes on a harness and it houses a 3.6V AA battery, a Bluetooth transceiver and a buzzer.
The ECG signals are transmitted via Bluetooth to a handheld device with a proprietary interactive application, configured to process and transmit the ECG recordings. The handheld device is a mobile computing device with a display and a touch input such as a cell-phone. It has sufficient memory and processing capability to run the proprietary application.
When an arrhythmia event is detected the handheld device transmits the recorded ECG information automatically via cellular link, to the Monitoring Center or professional analysis. When cellular service is unavailable the patient has an option to transmit via landline telephone.
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K Number
K083174Device Name
HEALTHEPOD
Manufacturer
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
Date Cleared
2009-12-17
(416 days)
Product Code
DXH, FLL
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HealthePod is a medical device designed for self-testing. It comprises the following medical features:
- ECG 1-lead .
- Heart rate .
- Body temperature ●
Device Description
The Card Guard® CG-1411USB HealthePod is a medical and non-medical monitor designed for self-testing by patients. It contains 4 sensors designed to execute the following features:
- . ECG 1-lead
- . Heart rate
- . Ambient temperature
- Body temperature .
- Pedometer walking steps and walking distance, .
- Calorie Meter .
- Stopwatch, Count down, Alarm clock .
- Date/Time .
HealthePod can communicate measured data and patient information to a PC with a receiving medical Application such as PMP4. Two dry electrodes are assembled on the device PCB. It features an LCD, three buttons and a USB connector for communication with PC.
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K Number
K082521Device Name
EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM
Manufacturer
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
Date Cleared
2009-01-16
(136 days)
Product Code
NBW, CGA, DXN
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Easy2Check blood glucose and blood pressure monitoring system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in the systems can be used only during steady-state blood glucose conditions.
The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4"~13.8".
This system offers wireless communication function which is able to transmit the test result to other devices, such as PC.
Device Description
PMP4 Easy2Check Personal Wireless Blood Pressure and Blood Glucose Monitor. The system measures glucose in fresh capillary whole blood and measures non-invasively the systolic and diastolic blood pressure and pulse rate. It has wireless communication function.
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K Number
K081257Device Name
CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
Manufacturer
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
Date Cleared
2008-05-29
(27 days)
Product Code
DSI
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm, or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.
Device Description
The CG-6108 ACT-3L is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center. It comprises a chest-worn ECG sensor and a handheld device with a proprietary application, configured to process and transmit the ECG recordings.
The chest-worn unit has 3 electrodes on a harness and it houses a battery, an ASIC and a Bluetooth transceiver for the acquisition, recording, and transmission of the ECG signal.
The ECG signals are transmitted via Bluetooth to the handheld device. When an event is detected it is wirelessly transmitted to the CG Monitoring Center for professional analysis. The handheld device is equipped with shared memory used to received from the sensor and to allow preand post processing options through the use of this memory in a dual memory loop configuration, both running in parallel. One loop is auto-triggered, with programmable that starts recording based on specific rhythms detected or manually activated by the patient. The second, and longer, recording loop is controlled to provide the physician with more information, when requested by the CG Monitoring Center.
The handheld device automatically transmits the recorded ECG, via cellular link, to the Monitoring Center. When cellular service is unavailable the patient can transmit via landline telephone.
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K Number
K071995Device Name
CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
Manufacturer
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
Date Cleared
2007-12-18
(151 days)
Product Code
DSI, DXH
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CG-6108 Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors a one lead ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.
Device Description
The CG-6108 Continuous ECG Monitor and Arrhythmia Detector system is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center. It comprises a chest-worn ECG sensor and a handheld device with a proprietary application, configured to process and transmit the ECG recordings. The chest-worn unit includes 3 electrodes on a harness and it houses a battery, an ASIC and a Bluetooth transceiver for the acquisition, recording, and transmission of the ECG signal. The ECG signals are transmitted via Bluetooth to the handheld device. When an event is detected it is wirelessly transmitted to the CG Monitoring Center for professional analysis. The handheld device is equipped with shared memory used to record the signal received from the sensor and to allow pre- and post processing options through the use of this memory in a dual memory loop configuration, both running in parallel. One loop is auto-triggered, with programmable thresholds that starts recording based on specific rhythms detected or manually activated by the patient. The second, and longer, recording loop is controlled remotely to provide the physician with more information, when requested by the CG Monitoring Center. The handheld device automatically transmits the recorded ECG, via cellular link, to the Monitoring Center. When cellular service is unavailable the patient can transmit via landline telephone.
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K Number
K061428Device Name
PMP4 APPLICATION
Manufacturer
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
Date Cleared
2006-10-16
(146 days)
Product Code
MSX
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PMP4 Application is intended for: a) Patients wishing to acquire, display and transmit their vital signs to a medical professional via Webbased Call Center for analysis and obtain response b) Physicians for medical testing of patients' vital signs, display and analysis as well as follow up and response to patient's transmitted data
Device Description
Not Found
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K Number
K061528Device Name
SELFCHECK GLUCO
Manufacturer
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
Date Cleared
2006-09-22
(112 days)
Product Code
CGA, JJX, NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Card Guard SelfCheck Gluco glucose test system is intended for use in the quantitative measurement of glucose in whole blood taken from the finger. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Device Description
Not Found
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K Number
K060911Device Name
CG-6108 ARRHYTHMIA ECG EVENT RECORDER
Manufacturer
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
Date Cleared
2006-08-22
(141 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia
Device Description
The CG-6108 system is an Arrhythmia ECG Event Recorder designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center. It comprises a chestworn ECG sensor and a handheld device with a proprietary application, configured to process and transmit the ECG recordings. The chest-worn unit includes 3 electrodes on a harness and it houses a battery, an ASIC and a Bluetooth transceiver for the acquisition, recording, and transmission of the ECG signal. The ECG signals are transmitted via Bluetooth to the handheld device. When an event is detected it is wirelessly transmitted to the CG Monitoring Center for professional analysis. The handheld device is equipped with shared memory used to record the signal received from the sensor and to allow preand post processing options through the use of this memory in a dual memory loop configuration, both running in parallel. One loop is auto-triggered, with programmable thresholds, that starts recording based on specific rhythms and arrhythmias detected or manually activated by the patient. The second, and longer, recording loop is controlled remotely to provide the physician with more information, when requested by the CG Monitoring Center. The handheld device automatically transmits the recorded ECG, via cellular link, to the Monitoring Center. When cellular service is unavailable the patient can transmit via landline telephone.
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