S-Patch Ex Wearable ECG Patch— 510(k) K231289

Substantially Equivalent

Wellysis Corp.

FDA 510(k) clearance K231289 for S-Patch Ex Wearable ECG Patch, Substantially Equivalent on 2023-08-30. Applicant: Wellysis Corp..

Clearance details

Applicant: Wellysis Corp.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 2023-05-04
Decision date: 2023-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.