DeviceClearance

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.. Device class: 2.

Summary

Smwmed's Rhythm Master ECG Patch comes in three models (HM-15BB-AX, HM-15BW-AX, and HM-15BW-DX), filed under product code DSH (Recorder, Magnetic Tape, Medical).

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

Smwmed filed from San Diego, California. Review took 266 calendar days (July 31, 2025 to April 23, 2026).

Clearance details

Applicant
Smwmed, Inc.
Product code
Product code DSH
Device class
Class 2
Regulation
21 CFR 870.2800
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code DSH

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Adverse events under product code DSH

product code DSH
Death
3
Injury
652
Total
655

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.