Peerbridge COR MDx (Cor MDx)
Device Facts
| Record ID | K253529 |
|---|---|
| Device Name | Peerbridge COR MDx (Cor MDx) |
| Applicant | Peerbridge Health, Inc. |
| Product Code | MWJ · Cardiovascular |
| Decision Date | Sep 4, 2026 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 870.2800 |
| Device Class | Class 2 |
Indications for Use
The Peerbridge Cor MDx device is a retrospective ambulatory electrocardiogram (ECG) recorder with a patient-activated event button, intended to record external ECG data for up to fourteen (14) days. It is indicated for use on adult patients eighteen (18) years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety. Recorded ECG data is provided for manual retrospective review and interpretation by qualified clinical personnel following the wear period. The Cor MDx device does not perform automated arrhythmia detection, real-time analysis, or diagnostic interpretation. The Cor MDx device itself is only intended for manual interpretation and is not intended for ST segment analysis, ischemia detection, or myocardial infarction detection.
Device Story
Retrospective ambulatory ECG recorder; records continuous two-channel ECG for up to 14 days; includes patient-activated event button for 2-minute strips. System comprises wearable ECG sensor, single-use adhesive electrode, mobile app (BYOD), cloud-based clinical portal, and reprocessing application. Used in home/healthcare settings; operated by patient. Data stored on-device until end-of-study download; reprocessing application generates full disclosure report for manual review by qualified clinical personnel. No automated analysis, arrhythmia detection, or real-time interpretation. Benefits include extended monitoring duration for transient symptom capture.
Clinical Evidence
Bench testing only. Testing included ECG signal-to-noise ratio (IEC 60601-2-47), 14-day functional recording, electrical/mechanical/thermal safety (IEC 60601-1), defibrillation safety, EMC (IEC 60601-1-2), wireless coexistence (AAMI TIR 69/ANSI C63.27), biocompatibility (ISO 10993), and usability (IEC 62366-1).
Technological Characteristics
Two-channel ECG; 200 Hz sampling; 16-bit resolution; 0.5-40 Hz frequency response. Ag-AgCl wet electrodes; inverted L-shape geometry. 16 Gb NAND flash memory. Qi wireless charging. Connectivity: BYOD mobile app (iOS/Android), cloud-based clinical portal, OTA firmware updates. Standards: IEC 60601-1, IEC 60601-2-47, ISO 10993, IEC 62304.
Indications for Use
Indicated for adult patients 18+ years, asymptomatic or experiencing transient symptoms (palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, anxiety).
Regulatory Classification
Identification
A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.
Predicate Devices
- Peerbridge Cor System (Cor 1.0) (K171936)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
September 4, 2026
Peerbridge Health, Inc.
% Dulciana Chan
Consultant
Avania CRO
3 Columbus Cir. 15th Floor,
New York, NY 10019 USA
Re: K253529
Trade/Device Name: Peerbridge COR MDx (Cor MDx)
Regulation Number: 21 CFR 870.2800
Regulation Name: Medical Magnetic Tape Recorder
Regulatory Class: Class II
Product Code: MWJ
Dated: August 11, 2026
Received: August 11, 2026
Dear Dulciana Chan:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253529 - Dulciana Chan
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
JENNIFER W. SHIH -S
Jennifer Kozen
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics, and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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# Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253529 | ? |
| --- | --- | --- |
| Please provide the device trade name(s). | | ? |
| Peerbridge Cor MDx (Cor MDx) | | |
| Please provide your Indications for Use below. | | ? |
| The Peerbridge Cor MDx device is a retrospective ambulatory electrocardiogram (ECG) recorder with a patient-activated event button, intended to record external ECG data for up to fourteen (14) days. It is indicated for use on adult patients eighteen (18) years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety. Recorded ECG data is provided for manual retrospective review and interpretation by qualified clinical personnel following the wear period. The Cor MDx device does not perform automated arrhythmia detection, real-time analysis, or diagnostic interpretation. The Cor MDx device itself is only intended for manual interpretation and is not intended for ST segment analysis, ischemia detection, or myocardial infarction detection. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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Peerbridge Health, Inc.
## 510(k) Summary
Summary of safety and effectiveness prepared per 21 CFR 807.92
| Submission | K253529 |
| --- | --- |
| Device | Peerbridge Cor MDx Retrospective Ambulatory ECG Recorder |
| Prepared by | Peerbridge Health, Inc. |
### 1. Submitter Information
Peerbridge Health, Inc.
3 Columbus Circle, Floor 15, New York, NY 10019 (877)
426-7457
Prepared by: Chris Darland, CEO on September 4, 2026
### 2. Device Identification
| Attribute | Subject Device |
| --- | --- |
| Trade / Proprietary Name | Peerbridge Cor MDx |
| Common / Usual Name | Ambulatory electrocardiograph (ECG) recorder |
| Classification Name | Electrocardiograph, ambulatory (without analysis) |
| Regulation | 21 CFR 870.2800 Medical magnetic tape recorder |
| Product Code | MWJ |
| Device Class | Class II |
### 3. Predicate Device
Substantial equivalence is claimed to the Peerbridge Cor System (Cor 1.0), cleared under K171936. The predicate is a Class II device under 21 CFR 870.2800, product code DSH. The Cor MDx and the predicate share the same intended use and the same fundamental ECG acquisition technology.
### 4. Device Description
The Peerbridge Cor MDx is a retrospective ambulatory ECG recorder comprising a reusable Wearable ECG Sensor, a single-use Adhesive Electrode, a mobile application (for a bring your
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own device (BYOD)), a Cloud-based Clinical Platform (the Clinical Portal and PBTS API (traceability API)), and a Reprocessing Application. The device records continuous two-channel ECG for up to fourteen (14) days. A patient-activated event button records a two-minute strip (sixty seconds before and sixty seconds after activation). The complete ECG record is stored on device until end-of-study download.
Following end-of-study device return and download, the Reprocessing Application generates the Full Disclosure Report and delivers it directly to the Clinical Portal, and standard ECG format files are delivered directly to qualified clinical personnel, in both cases for manual retrospective review and interpretation following the wear period. The Cor MDx device itself does not perform automated ECG analysis, arrhythmia detection, beat detection, or clinical interpretation of any kind.
### 5. Indications for Use
The Peerbridge Cor MDx device is a retrospective ambulatory electrocardiogram (ECG) recorder with a patient-activated event button, intended to record external ECG data for up to fourteen (14) days. It is indicated for use on adult patients eighteen (18) years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety. Recorded ECG data is provided for manual retrospective review and interpretation by qualified clinical personnel following the wear period.
The Cor MDx device does not perform automated arrhythmia detection, real-time analysis, or diagnostic interpretation. The Cor MDx device itself is only intended for manual interpretation and is not intended for ST segment analysis, ischemia detection, or myocardial infarction detection.
### 6. Technological Characteristics and Comparison to the Predicate
The Cor MDx preserves the fundamental ECG acquisition architecture of the predicate, including the two-channel configuration (Channel 2 and Channel 3), the 200 Hz sampling rate, the 16-bit resolution, the 0.5 Hz to 40 Hz frequency response, the electrode geometry and footprint, and the Ag-AgCl wet electrode configuration. The differences between the Cor MDx and the predicate are technological enhancements that do not alter the fundamental ECG acquisition technology, electrode geometry, or intended use.
| Characteristic | Predicate (Cor 1.0 K171936) | Cor MDx (K253529) |
| --- | --- | --- |
| ECG channels | Channel 2 and Channel 3 | Channel 2 and Channel 3 |
| Sampling / resolution | 200 Hz; 16-bit; 0.5 to 40 Hz | 200 Hz; 16-bit; 0.5 to 40 Hz |
| Electrode geometry | Inverted L-shape Ag-AgCl, fixed spacing | Inverted L-shape Ag-AgCl, fixed spacing |
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| Maximum recording duration | Up to 7 days | Up to 14 days |
| --- | --- | --- |
| Mobile platform | Pre-loaded Android device with Peerbridge Mobile Application | BYOD iOS or Android with Peerbridge Mobile Application |
| Memory | 8 gigabit NAND flash | 16 gigabit NAND flash |
| Charging | USB charging fixture | Qi wireless |
| Firmware update | No OTA capability | Over-the-air (OTA) update capability |
| Intended use | Ambulatory ECG recording for manual retrospective review | Ambulatory ECG recording for manual retrospective review |
| Re-Use | Wearable ECG Sensor: multi-patient Adhesive Electrode: single use | Wearable ECG Sensor: multi-patient Adhesive Electrode: single use |
| Use Environment | Home and Healthcare settings | Home and Healthcare settings |
### 7. Performance Data
The following nonclinical performance testing was provided to support the substantial equivalence of the Cor MDx.
| Test | Standard / Reference |
| --- | --- |
| ECG signal-to-noise ratio | IEC 60601-2-47 Annex AA.3.3 |
| 14-day functional recording | Design verification (continuous 14-day recording) |
| Post-packaging performance | ISTA 3A |
| Electrical / mechanical / thermal safety | IEC 60601-1, IEC 60601-2-47 |
| Defibrillation safety | IEC 60601-1 Clause 8.5.5 |
| Electromagnetic compatibility | IEC 60601-1-2:2014/AMD1:2020 |
| Wireless coexistence | AAMI TIR 69 Category C / ANSI C63.27 Tier 3 (retrospective, non-alerting) |
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| Reprocessing Application verification | Design verification |
| --- | --- |
| Biocompatibility | ISO 10993-5, ISO 10993-10 |
| Software | IEC 62304; FDA software guidance (2023) |
| Cybersecurity | FDA premarket cybersecurity guidance |
| ECG signal characterization | Cor MDx ECG Signal Characterization and Placement Accuracy ; IEC 60601-2-47 |
| Usability | IEC 62366-1:2015+AMD1:2020; FDA Human Factors guidance |
| Battery/power | Design verification |
No new clinical testing was required to support substantial equivalence.
### 8. Substantial Equivalence Conclusion
The Peerbridge Cor MDx has the same intended use as the predicate Peerbridge Cor 1.0 device (K171936) and the same fundamental scientific technology for ECG acquisition. The technological differences do not alter the fundamental ECG acquisition technology, electrode geometry, or intended use, and do not raise new questions of safety or effectiveness. The nonclinical performance data demonstrate that the Cor MDx performs as intended and is as safe and effective as the predicate. Peerbridge Health concludes that the Peerbridge Cor MDx is substantially equivalent to the predicate device K171936.
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