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FDA 510(k)

MEMO Patch M (MPT-E08R-UNC01)

K-Number: K243438 · 2025-12-05

ApplicantHuinno Co., Ltd.
Decision Date2025-12-05
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEMO Patch M (MPT-E08R-UNC01) is the device name listed in this FDA 510(k) record. The listed applicant is Huinno Co., Ltd.. It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K243438. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEMO Patch M (MPT-E08R-UNC01)?

MEMO Patch M (MPT-E08R-UNC01) is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Huinno Co., Ltd.. The 510(k) number is K243438.

When did MEMO Patch M (MPT-E08R-UNC01) receive FDA 510(k) clearance?

MEMO Patch M (MPT-E08R-UNC01) received FDA 510(k) clearance on 2025-12-05, under 510(k) number K243438.

Who is the listed applicant for MEMO Patch M (MPT-E08R-UNC01)?

The FDA 510(k) record lists Huinno Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEMO Patch M (MPT-E08R-UNC01)?

The FDA product code for MEMO Patch M (MPT-E08R-UNC01) is DXH. This falls under the Hematology category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07722026This Exploratory Medical Device Study Evaluated the Arrhythmia Diagnostic Yield of MEMO Patch V2, a Wearable Patch-type Electrocardiographic Monitor, in Adults With Suspected Arrhythmia Who Presented With Symptoms Such as Palpitations or Dizziness, or Who Had Cryptogenic Ischemic Stroke or TransientCOMPLETEDNCT07725445Evaluation of an AI-Based Lightweight ECG Telemetry Monitoring SystemCOMPLETEDNCT077285527-Day MEMO Patch Monitoring for Arrhythmia Detection in Patients With PalpitationsCOMPLETEDNCT07736066Remote ECG Monitoring-Based Phase I Cardiac Rehabilitation After Heart SurgeryCOMPLETEDNCT07792772Arrhythmia Detection With MEMO Patch Plus in Patients With Acute Heart FailureCOMPLETEDNCT07722039Clinical Validation of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 HoursNOT_YET_RECRUITING

Related Devices (Code: DXH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.K222842V-Patch Cardiac MonitorShandong Corecare Technology Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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