FDA 510(k)

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

Número K: K252389 · 2026-04-23

Data da decisão2026-04-23

Código do produtoDSH

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Smwmed, Inc.. The 510(k) number is K252389.

When did Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) receive FDA 510(k) clearance?

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

Who is the listed applicant for Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)?

The FDA 510(k) record lists Smwmed, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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