# K222842: V-Patch Cardiac Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Corecare Technology Limited
- Decided: Oct 20, 2022 after 30 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K882803 (1988). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193296: eCordum Cardiac Monitor (eCordum CM), Ecordum, Inc. (2020) Summary page 4.

## Most influential descendants
- K243438: MEMO Patch M (MPT-E08R-UNC01) (2025), 0 descendants of its own

## Indications for use
The V-Patch Cardiac Monitor is intended to record, transfer and store single-channel electrocardiogram (ECG) data via Bluetooth transmission to Bluetooth enabled devices. The monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. The ECG data is intended to supplement other patient data and is not intended for automated analysis. The device has not been tested and it is not intended for pediatric use.

Source page: https://510kreport.com/device/K222842
Methodology: https://510kreport.com/methodology