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

Name: FDA 510(k) clearance K231289
Creator: U.S. Food and Drug Administration
Published: 2023-08-30

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.. Device class: 2.

Clearance details

Applicant: Wellysis Corp.
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
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 ↗

Recent devices under product code DSH

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K260157 — LifeLens Physiological Monitor2026-07-09
K252389 — Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)2026-04-23
K253293 — VitaloJAK Clinic (Model 7100)2025-12-03
K243650 — Zio® monitor (DFG0001)2025-08-15
K243603 — AeviceMD2025-05-05

More clearances from Wellysis Corp.

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K233906 — S-Patch (S-Patch ExL)2024-02-16

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.