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510(k) Data Aggregation
K Number
K162665Device Name
MiCor A100 Wearable ECG Recorder
Manufacturer
Date Cleared
2018-01-26
(487 days)
Product Code
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
MITAC INTERNATIONAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended for use by users who have transient symptoms that may suggest cardiac conduction abnormalities or by users who wants to monitor the cardiac function at home health care from Lead 1 ECG signal.
ECG acquisition and transmission is voluntary and mutually activated by the user. The intend users are adult.
The device is design to let user wear on wrist and record ECG signal while user feel transient cardiac abnormalities symptoms any time.
Users with implanted pacemaker are not recommended to use this device.
Device Description
MiCor A100 Wearable ECG Recorder is an easy-to-use electrocardiograph unit that can record and store electrocardiogram (ECG) measurements of users' heart rhythm. ECG acquisition and transmission is voluntary and mutually activated by the user. The intended users are adult. The device is designed to let user wear on wrist and record ECG signal while user feel transient cardiac abnormalities symptoms any time. Users with implanted pacemaker are not recommended to use this device.
The device is the wristband as wearable style. It is smaller and light weight, dry electrode and affordable ECG recording device. Its primary function is recording ECG signal of user/patient with one finger press on top of ECG plate of device. The device will record the user/patient ECG signal for 30 seconds and automatically store into build-in memory, meanwhile, the device also display the real time heart rate. The device can store 30 sets of ECG signal (30 seconds / set of data), then user can transfer ECG signal data from device to APP of the iPhone via BLE. The APP can display ECG of each recording ECG signal. And user can print the ECG and let his Cardiologist to refer and diagnose.
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