# K162665: MiCor A100 Wearable ECG Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Mitac International Corp.
- Decided: Jan 26, 2018 after 487 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K963725 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042814: Readmyheart, Dailycare Biomedical, Inc. (2005) Summary page 5.

## Indications for 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.

Source page: https://510kreport.com/device/K162665
Methodology: https://510kreport.com/methodology