DeviceClearance

ZywieZ3 Sensor & Adhesive— 510(k) K252839

Substantially Equivalent

Zywie, Inc.

FDA 510(k) clearance K252839 for ZywieZ3 Sensor & Adhesive, Substantially Equivalent on 2026-06-18. Applicant: Zywie, Inc.. Device class: 2.

Summary

Zywie's ZywieZ3 Sensor & Adhesive is filed under MWJ, ambulatory electrocardiographs without analysis. The record doesn't describe the sensor or adhesive beyond the name and the code name.

Class II, 21 CFR 870.2800. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Zywie filed from Johns Creek, Georgia. Review took 286 calendar days (September 5, 2025 to June 18, 2026).

Clearance details

Applicant
Zywie, Inc.
Product code
Product code MWJ
Device class
Class 2
Regulation
21 CFR 870.2800
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Johns Creek, GA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MWJ

product code MWJ
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.