FDA.reportPublic FDA data

SCOTTCARE CORPORATION, THE

GUDID#

EZLink-R

SCOTTCARE CORPORATION, THE

2024-05-23

EZLink-C

SCOTTCARE CORPORATION, THE

2024-05-23

TeleSenseRCM - The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms orasymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records thedata, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, andautomatically transmits the recorded event activity associated with these symptoms for review by a licensedphysician.The TeleSense is a battery powered device to be used to measure, record, store and/or remotely transfer theElectrocardiogram (ECG) noninvasively in mobile patients. The available data transfer methods are USB and Wi-Fi.TeleSense is not limited to certain patient groups or pathologies; however, the TeleSense is not intended forpediatric use. Examples of applications are:- Cardiology- Pulmonary Care- Home Care- General PractitionersContraindications:a. Patients with potentially life-threatening arrhythmias who require inpatient monitoring.b. Patients who the attending physician thinks should be hospitalized.

SCOTTCARE CORPORATION, THE

2016-09-19

TeleSense-E - The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms orasymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records thedata, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, andautomatically transmits the recorded event activity associated with these symptoms for review by a licensedphysician.The TeleSense is a battery powered device to be used to measure, record, store and/or remotely transfer theElectrocardiogram (ECG) noninvasively in mobile patients. The available data transfer methods are USB and Wi-Fi.TeleSense is not limited to certain patient groups or pathologies; however, the TeleSense is not intended forpediatric use. Examples of applications are:- Cardiology- Pulmonary Care- Home Care- General PractitionersContraindications:a. Patients with potentially life-threatening arrhythmias who require inpatient monitoring.b. Patients who the attending physician thinks should be hospitalized.

SCOTTCARE CORPORATION, THE

2016-09-19

HolterCare - The ScottCare HolterCare Analysis System is intended for general hospital or clinical use bymedical professionals whenever it is required to assess a patient’s long-term, continuous,ambulatory electrocardiogram (ECG). The long-term ECG is recorded on a digital flash memoryHolter recorder. This product allows a trained physician, or other health care professional, todownload and analyze the data from the recorder, review it, and produce printed reports. This willenable: The evaluation of arrhythmias and ischemic attacks. The reporting of PQRST intervals. Clinical and epidemiological research studies. The evaluation of a patient’s response after resuming occupational or recreational activities (e.g.,after M.I. or cardiac surgery). The evaluation of patients with Pacemakers.The need to record, review, edit, and archive the ambulatory ECG is most commonly encountered inthe Cardiology areas of the hospital, or physician’s office, during cardiac assessment of a patient.This device is available for sale to, or on the order of, a licensed physician only and is not intendedfor any home-use applications.

SCOTTCARE CORPORATION, THE

2016-09-19

ABPCare

SCOTTCARE CORPORATION, THE

2016-09-19

EZLink

SCOTTCARE CORPORATION, THE

2016-09-19

EventCare - The EventCare Event Monitoring System allows for the performance of traditional acoustic arrhythmia monitoring andthe utilization of cellular event transmissions and monitoring. The system helps to maintain an accurate inventory ofdevices, patients’ records ECG events and reports. The system can also produce a wide array of administrativereports to help manage your monitoring operations. This program provides fast, accurate access to your patients’events and Electrocardiographic recordings, regardless of time or location. EventCare allows you to receive live orrecorded ECG transmissions over ordinary telephone lines, as well as cellular telephony networks, edit the ECG righton the computer screen, then print out a detailed, professional report.

SCOTTCARE CORPORATION, THE

2016-09-19

OneView - ScottCare’s OneView is an innovative, cardiology software tool used to simplify and streamline thepacemaker/ICD monitoring session reporting process by consolidating all device manufacturers’ session datainto one, convenient platform.With a click of a button, OneView captures all relevant pacemaker/ICD data, including: Device specifications Measurements for every session Settings Episode details Reports Physician sign-offOneView also provides insight into historical patient trends and other critical clinical data over time, helping toprioritize patients with more severe issues. In addition, data can be gathered from almost anywhere, as itsupports remote interrogation, in-person interrogation and in-person programming.

SCOTTCARE CORPORATION, THE

2016-09-19

TeleRehab Software File Manager - The ScottCare VersaCare Cardiopulmonary Monitoring System is designed to allow monitoring andrecording of electrocardiograph (ECG) rhythm strips and related information for patients undergoingan exercise therapy program. Patients are monitored by medical telemetry exercise monitoringequipment. This feature allows patients to comply with exercise prescriptions while exercising at amedical/rehabilitation facility near their home, or by returning to the primary medical facility toparticipate in an in-house cardiopulmonary rehabilitation program. VersaCare includes a ProgramManagement module that prints a variety of reports.

SCOTTCARE CORPORATION, THE

2016-09-19

TeleRehab Software Work Station/Seat License - The ScottCare VersaCare Cardiopulmonary Monitoring System is designed to allow monitoring andrecording of electrocardiograph (ECG) rhythm strips and related information for patients undergoingan exercise therapy program. Patients are monitored by medical telemetry exercise monitoringequipment. This feature allows patients to comply with exercise prescriptions while exercising at amedical/rehabilitation facility near their home, or by returning to the primary medical facility toparticipate in an in-house cardiopulmonary rehabilitation program. VersaCare includes a ProgramManagement module that prints a variety of reports.

SCOTTCARE CORPORATION, THE

2016-09-19