FDA 510(k) · Huinno
K243438: MEMO Patch M (MPT-E08R-UNC01) (Huinno Co., Ltd.)
Huinno Co., Ltd. received FDA 510(k) K243438 for MEMO Patch M (MPT-E08R-UNC01), with a decision date of Dec 5, 2025 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K243438 |
|---|---|
| Pathway | 510(k) |
| Applicant | Huinno Co., Ltd. |
| Device name | MEMO Patch M (MPT-E08R-UNC01) |
| Product code | DXH: Transmitters And Receivers, Electrocardiograph, Telephone |
| Regulation (21 CFR) | 870.2920 |
| Device class | Class 2 |
| Date received | Nov 6, 2024 |
| Decision date | Dec 5, 2025 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K222842 V-Patch Cardiac Monitor (Shandong Corecare Technology)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DXH is "Transmitters And Receivers, Electrocardiograph, Telephone", class 2, 21 CFR 870.2920.
Our labels for filtering: claim ECG, sensor ECG electrodes. These are heuristics, not FDA fields.