Cardiovascular · 510(k) · 2024
ASSURE Wearable ECG
Kestra Medical Technologies, Inc.. Cleared by FDA on 7 May 2024 under submission K233864, product code MWJ (electrocardiograph, ambulatory (without analysis)). What FDA's record says, in FDA's words.
Device record · K233864
- Device. ASSURE Wearable ECGDEVICE
- Company. Kestra Medical Technologies, Inc.COMPANY
- Decision. 7 May 2024, 510(k), substantially equivalent (traditional review); received 6 December 2023DECISION
- Panel. CardiovascularPANEL
- Product code. MWJ, Electrocardiograph, Ambulatory (Without Analysis)CODE
- Regulation. 21 CFR 870.2800, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The ASSURE Wearable ECG is indicated for adult patients who have been prescribed this device by a medical professional, who were previously prescribed the ASSURE WCD system, and who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light- headedness, presyncope, syncope, fatigue, or anxiety. The signal acquired by the ASSURE Wearable ECG is K 233864 Page 2 not intended and should not be used for automated or semi-automated analysis. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support. The ASSURE Wearable ECG is contraindicated for use in patients with an active implantable pacemaker or defibrillator.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 63 reports filed against devices carrying product code MWJ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
23 June 2026 · Malfunction · HOLTER RECORDER · UNKNOWN · report MW5189854
DESCRIPTION OF EVENT IT WAS REPORTED THAT THE MONITOR GOT WET AND WAS NOT WORKING. THERE WAS NO PATIENT OR USER HARM. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
5 March 2026 · Other · HOLTER MONITOR - EKG MACHINE · UNKNOWN · report MW5184815
DATE THE PROBLEM OCCURRED: FALL 2018. THE DEPARTMENT OF TRANSPORTATION REQUIRED ME TO HAVE STRESS TESTING. SINCE DOING THE STRESS TEST AND WEARING A HALTER MONITOR ¿ EKG MACHINE. I HAVE EXPERIENCED MORE PHYSICAL DIFFICULTIES. THEY USED DIFFERENT MEDICINES TO CONTROL MY HEART RATE. TH NURSES DOING THE TEST WERE STUDENTS AT THE TIME AS WELL. I WOULD LIKE THIS TO BE INVESTIGATED AND TO KNOW FOR CERTAIN THAT THE TESTING MACHINES ARE NOT BEING USED TO CONTINUE CAUSING ME MEDICAL PROBLEMS. AFTER ALL […]
8 December 2025 · Malfunction · H12+ HOLTER RECORDER-REPAIR ONLY · MORTARA INSTRUMENT · report 2183461-2025-00023
THE CUSTOMER REPORTED THAT AFTER PLACING A HOLTER ECG DEVICE ON AN EXTERNAL PATIENT, THE PATIENT RETURNED HALF AN HOUR LATER COMPLAINING OF BURNING SENSATIONS. WHEN EXAMINED, THE PATIENT PRESENTED SKIN REDNESS IN THE AREA UNDERNEATH THE DEVICE, AND THE DEVICE BURNED TO THE TOUCH AND WAS OFF. THE CUSTOMER ALSO NOTED THAT WHEN THEY OPENED THE DEVICE'S COVER, THE BATTERY HAD EXPLODED. THERE WAS NO REPORT OF MEDICAL INTERVENTION REQUIRED, AND NO FURTHER CLINICAL INFORMATION WAS PROVIDED BY THE […]
29 October 2025 · Malfunction · SPIDERFLASH · report 1000165971-2025-00691
REPORTEDLY, THE DEVICE WAS CONNECTED AND WORKING DURING THE FULL 7 DAYS, HOWEVER NO ECG WAS RECORDED. THE CLIENT WANTS TO KNOW BASED ON THE FILES IF THE DEVICE MIGHT HAVE A PROBLEM. MEANWHILE THEY PERFORMED A QUICK 10 MIN TEST AND ALL SEEMS NORMAL. THE DEVICE WILL BE USED AGAIN.
20 October 2025 · Malfunction · DIGITRAK XT HOLTER · PHILIPS MEDICAL SYSTEMS · report 23335138
COWORKER REACHED OUT TO ME. PATIENT RETURN HOLTER TO THE [REDACTED] OFFICE. WHEN THEY WENT TO DOWNLOAD IT, THE HOLTER DISPLAYED AN ERROR MESSAGE. WE WERE UNABLE TO DOWNLOAD THE HOLTER AND SEE THE REORDERED INFORMATION. BILLERS WERE ASKED TO CREDIT THE HOOK-UP, ORDERING MD WAS ASKED IF THEY WANT THE HOLTER REPEATED. HOLTER WAS PULLED FROM SERVICE AND SENT FOR REPAIR.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code MWJ, in Cardiovascular, or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.