AT-Patch ECG Analysis System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- AT-Patch EUDAMEDFDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser FDA UDI
- Device Name
- AT-Patch EUDAMED
- Model / Reference
- ATP-C130 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800069700345 EUDAMED08800069700338 EUDAMED08800069700178 FDA UDI
- Basic UDI-DI
- B-08800069700345 EUDAMEDB-08800069700338 EUDAMED
- 510(k) Number
- K203638 FDA 510(k)
- FDA Product Code
- DSH FDA 510(k)FDA UDIDQK FDA UDI
- EMDN Code
- Z12050401 CARDIOVASCULAR HOLTER ANALYSERS EUDAMED
- GMDN Term
- Electrocardiographic long-term ambulatory recording analyser 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 UDI870.1425 FDA UDI
- Market of Registration
- Germany EUDAMEDGreece 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
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
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
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The AT-Patch ECG Analysis System is a wearable, portable device designed for continuous electrocardiogram (ECG) monitoring and analysis. It functions as a recorder for ECG signals, enabling long-term cardiac rhythm assessment and arrhythmia detection in clinical settings.
The system is supplied as a reusable, non-sterile medical device intended for on-premise use in healthcare institutions. It operates under FDA 510(k) clearance and MDD compliance, with no indication of MRI safety restrictions. The device is available in the model variant ATPC130 and adheres to regulatory standards for cardiovascular monitoring devices (regulation number 870.2800).
Frequently asked questions
What is the primary purpose of the AT-Patch ECG Analysis System, and how does it differ from traditional ECG monitoring methods?
The AT-Patch ECG Analysis System is designed for continuous, wearable ECG monitoring, allowing for long-term assessment of cardiac rhythm and arrhythmia detection in clinical settings. Unlike traditional ECG machines that require wired electrodes and stationary use, this system is portable and wearable, enabling patients to move freely while still being monitored. It functions as a recorder for ECG signals, making it ideal for extended observation without the constraints of fixed equipment.
Is the AT-Patch ECG Analysis System reusable or single-use, and what are the implications for healthcare facilities?
The AT-Patch ECG Analysis System is reusable and non-sterile, meaning it is intended for on-premise use within healthcare institutions rather than patient take-home or home use. This design allows facilities to maintain the device for repeated clinical use, reducing disposal costs and waste. However, since it is non-sterile, it must be cleaned and maintained according to facility protocols to ensure hygiene and proper functionality between uses.
What model variants are available for the AT-Patch ECG Analysis System, and are there any size or configuration options?
The AT-Patch ECG Analysis System is currently available in one model variant: ATPC130. There is no additional information provided about size or configuration options beyond this single variant, which is designed for wearable, continuous ECG monitoring. If additional models or configurations are needed, they would need to be confirmed directly with the manufacturer.
How should the AT-Patch ECG Analysis System be stored, and are there any specific environmental or handling requirements?
While the device data does not specify exact storage conditions, as a reusable, non-sterile medical device, it should be stored in a clean, dry environment to prevent contamination and damage. Since it is intended for on-premise use in healthcare institutions, facilities should follow standard protocols for maintaining reusable medical equipment, including proper cleaning, calibration, and protection from physical stress or extreme temperatures. Always refer to the manufacturer’s instructions for detailed storage guidelines.
What regulatory pathways does the AT-Patch ECG Analysis System follow, and how does this affect its use in clinical settings?
The AT-Patch ECG Analysis System is FDA 510(k) cleared and compliant with the MDD (Medical Device Directive), indicating it meets U.S. and European regulatory standards for cardiovascular monitoring devices. This clearance confirms its safety and effectiveness for recording ECG signals and arrhythmia detection in clinical settings. The device falls under OpenFDA classification as a
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: ATsens, ATSens - Continuous ECG Monitoring, ATsens AT-Patch ECG Analysis System : User's Manual, ATPC130 AT-Patch ECG Analysis System User... - FCC ID 2AWWS-ATPC130
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K203638 | Class II | Active |
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Manufacturer
- Manufacturer
- ATsens.co., Ltd.
- FDA Applicant
- Atsens Co., Ltd.
Sources (4)
- FDA 510(k) K203638 24 fields · synced Sep 18, 2026
- FDA UDI 699f9b54-9fb3-4196-bd88-92a89b0a86d7 32 fields · synced May 30, 2026
- EUDAMED 1358ae2a-105a-464c-be7f-bc8476d987ff 61 fields · synced Jul 31, 2026
- EUDAMED 0302fb47-82ed-4500-baf2-c88a5dce28d1 61 fields · synced Aug 2, 2026