Dynamic ECG System Model TLC5000
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Dynamic ECG Systems EUDAMEDCONTEC FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- Dynamic ECG Systems EUDAMEDFDA UDI
- Model / Reference
- TLC5000 EUDAMEDFDA UDITLC5000, TLC6000 EUDAMED
- Description
- Dynamic ECG Systems FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945040100294 EUDAMEDFDA UDI
- Basic UDI-DI
- 69450401TLC6000GX EUDAMED
- Direct Marketing DI
- 06945040100294 EUDAMED
- 510(k) Number
- FDA Product Code
- MLO FDA 510(k)FDA UDI
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMED
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.2800 FDA 510(k)
- Regulation Number
- 870.2800 FDA 510(k)FDA UDI
- Market of Registration
- Poland EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The Dynamic ECG System Model TLC5000 is an ambulatory electrocardiograph with analysis algorithm, designed to continuously record and analyze 12-lead ECG waveforms. It falls under the classification of a portable, long-term cardiac monitoring device, enabling real-time and stored ECG data acquisition for diagnostic purposes in clinical and community settings.
This system is intended for use in medical institutions and community healthcare environments, providing 24-hour ECG waveform recording and analysis via connected PC software. Supplied as a reusable medical device, it adheres to FDA 510(k) and MDR regulatory standards. The device operates in non-MRI environments and requires proper storage and maintenance as outlined in its user manual.
Frequently asked questions
What types of healthcare settings is the Dynamic ECG System Model TLC5000 designed for, and how does it differ from traditional ECG devices in terms of usage?
The Dynamic ECG System Model TLC5000 is specifically designed for use in medical institutions and community healthcare environments, where continuous cardiac monitoring is required. Unlike traditional ECG devices that capture a single snapshot of heart activity, this system is an ambulatory electrocardiograph that provides 24-hour continuous recording and analysis of 12-lead ECG waveforms. This makes it ideal for long-term monitoring in settings where patients may not be confined to a hospital bed, such as outpatient clinics, home healthcare, or telemedicine programs.
Is the Dynamic ECG System Model TLC5000 a single-use or reusable device, and what maintenance considerations should be taken into account?
The Dynamic ECG System Model TLC5000 is not single-use—it is classified as a reusable medical device. Since it is intended for repeated use across multiple patients, proper storage and maintenance are critical to ensure accuracy and reliability. The manufacturer’s user manual outlines specific guidelines for cleaning, calibration, and upkeep to maintain performance, particularly in clinical and community settings where hygiene and functionality are paramount.
What regulatory pathways has the Dynamic ECG System Model TLC5000 followed, and what does this mean for its use in clinical practice?
The Dynamic ECG System Model TLC5000 has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) compliance, confirming its adherence to stringent safety and performance standards in both the U.S. and EU markets. This means it has been evaluated by regulatory bodies to ensure it is substantially equivalent to predicate devices and meets requirements for portable, long-term cardiac monitoring. Clinicians can rely on its regulatory approvals when integrating it into diagnostic workflows.
Can the Dynamic ECG System Model TLC5000 be used in environments where MRI procedures are performed, and why?
No, the Dynamic ECG System Model TLC5000 is not intended for use in MRI environments. The device is explicitly designed for non-MRI settings, meaning it should not be operated near magnetic resonance imaging machines. This restriction is due to potential electromagnetic interference risks that could compromise the device’s functionality or patient safety in such environments.
How does the system’s connectivity and software integration work, and what role does it play in diagnostic analysis?
The Dynamic ECG System Model TLC5000 connects to a PC software platform to enable real-time and stored ECG data acquisition. This integration allows clinicians to continuously monitor and analyze 12-lead ECG waveforms over extended periods (up to 24 hours), facilitating early detection of cardiac abnormalities. The software likely includes algorithms for automated analysis, helping streamline diagnostic workflows in both clinical and community healthcare settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TLC5000 Dynamic ECG Systems-CONTEC MEDICAL SYSTEMS CO.,LTD, TLC5000 ECG Systems User Manual | PDF | Usb | Electrocardiography - Scribd, CONTEC TLC5000 12-Lead ECG Holter Monitor with Color Display
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K101273 | Class II | Active |
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Manufacturer
- Manufacturer
- Contec Medical System Co., Ltd.
Sources (3)
- FDA 510(k) K101273 24 fields · synced Sep 18, 2026
- FDA UDI 69abd312-818b-4993-9223-dda8a4a10dab 34 fields · synced May 30, 2026
- EUDAMED 347ef17d-8b9e-4de7-837f-93c2f64a08bf 61 fields · synced Jul 8, 2026