# K243438: MEMO Patch M (MPT-E08R-UNC01)

- Pathway: 510(k) (Traditional)
- Applicant: Huinno Co., Ltd.
- Decided: Dec 5, 2025 after 394 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: 9 generations back to K882803 (1988). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222842: V-Patch Cardiac Monitor, Shandong Corecare Technology Limited (2022) Summary page 5.

## Indications for use
The MEMO Patch M is intended to record, transfer and store single-channel electrocardiogram via USB transmission to PC. 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/K243438
Methodology: https://510kreport.com/methodology