# K253384: mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)

- Pathway: 510(k) (Traditional)
- Applicant: Seers Technology Co., Ltd.
- Decided: Jun 25, 2026 after 268 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K950944 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231289: S-Patch Ex Wearable ECG Patch, Wellysis Corp. (2023) Summary page 5.

## Indications for use
mobiCARE Cardiac Monitoring System is a wearable, ambulatory ECG recorder. It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. mobiCARE Cardiac Monitoring System is intended for use by patients 18 years or older. The device is not intended for use with critical care patients or for real-time monitoring.

Source page: https://510kreport.com/device/K253384
Methodology: https://510kreport.com/methodology