# K233864: ASSURE Wearable ECG

- Pathway: 510(k) (Traditional)
- Applicant: Kestra Medical Technologies, Inc.
- Decided: May 7, 2024 after 153 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- 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 K963725 (1997). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211709: Biotres, Biotricity (2022) Summary page 4.
- K172311: BioFlux Device, Biotricity, Inc. (2017) Summary page 4.

## Indications for use
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 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.

Source page: https://510kreport.com/device/K233864
Methodology: https://510kreport.com/methodology