Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)— 510(k) K252389

Substantially Equivalent

Smwmed, Inc.

FDA 510(k) clearance K252389 for Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX), Substantially Equivalent on 2026-04-23. Applicant: Smwmed, Inc..

Clearance details

Applicant: Smwmed, Inc.
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 2025-07-31
Decision date: 2026-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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.