# K214073: eWave Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Wearlinq, Inc.
- Decided: Oct 20, 2022 after 297 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The eWave monitor is an ambulatory ECG monitor intended to provide continuous extended duration cardiac monitoring. It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, syncope, fatigue, or anxiety.

Source page: https://510kreport.com/device/K214073
Methodology: https://510kreport.com/methodology