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FDA 510(k)

Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)

K-Number: K252389 · 2026-04-23

ApplicantSmwmed, Inc.
Decision Date2026-04-23
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) is a medical device manufactured by Smwmed, Inc.. It received FDA 510(k) clearance on 2026-04-23 under approval number K252389. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)?

Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) is a medical device that received FDA 510(k) clearance on 2026-04-23. It is manufactured by Smwmed, Inc.. The 510(k) number is K252389.

When was Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) approved by the FDA?

Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) received FDA 510(k) clearance on 2026-04-23, under approval number K252389.

What company makes Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)?

Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) is manufactured by Smwmed, Inc..

What is the FDA product code for Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)?

The FDA product code for Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) is DSH.

Related Clinical Trials

NCT07118124 Pediatric Adhesion and New Dermal Approach Study COMPLETED

Related Devices (Code: DSH)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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