COREVENT The Peerbridge Cor™ System is a family of products comprised of two models, the Peerbridge Cor™ XT ("Cor XT") and the Peerbridge Cor™ Event ("Cor Event"). The system is an…
COREVENT The Peerbridge Cor™ System is a family of products comprised of two models, the Peerbridge Cor™ XT (“Cor XT”) and the Peerbridge Cor™ Event (“Cor Event”). The system is an ambulatory wearable ECG monitoring system designed to record and provide patient’s electrocardiogram (ECG) data to the clinician. The Peerbridge System consists of five components: (1) Wearable ECG Sensor with Bluetooth technology, (2) Adhesive Electrode (3) dedicated Handheld Transmitter Device, (4) Data Upload Fixture and Software that allow ECG data to be uploaded from the Wearable ECG Sensor to a PC and then to the Backend, and (5) Cloud-based Backend Data Management Module. The Wearable ECG sensor attaches to the patient’s chest and records the patient’s ECG continuously. This device can collect two (2) channels and 3-leads of ECG data continuously for up to seven (7) days. In addition, patients can report symptomatic events by pressing the Event Button on the Wearable ECG Sensor or by using the mobile application on the Handheld Transmitter when a symptom is experienced. The device generates ECG reports to be displayed on the clinician’s interface. The Peerbridge System Cor Event is configured for the following: – 24 hours of Holter monitoring – Patient Activated Event with Surveillance
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Peerbridge Cor System | Listed by | Peerbridge Health, Inc., United States |
| FDA product code | DSH |
| Device type | Recorder, Magnetic Tape, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K171936 |
| Record published | 2018-02-06 |
| Record revised | 2022-07-04 (version 8) |
Specifications
Specifications | MRI safety | MR Unsafe |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 90 % RH; Storage environment temperature 32 to 140 °F; Handling environment humidity 15 to 90 % RH; Handling environment temperature 32 to 104 °F |
| Packaging | Box of 5 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.