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510(k) Data Aggregation

    K Number
    K233906
    Device Name
    S-Patch (S-Patch ExL)
    Manufacturer
    Wellysis Corp.
    Date Cleared
    2024-02-16

    (66 days)

    Product Code
    DSH, MWJ
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wellysis Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    S-Patch ExL wearable ECG patch is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, fatigue, chest pain and/or anxiety. S-Patch ExL wearable ECG patch is intended for use by patients 18 years or older.
    Device Description
    The S-Patch ExL ECG Patch System ("S-Patch ExL") is a light-weight electrocardiogram ("ECG") data collection device. The S-Patch ExL operates wirelessly, and due to its compact size, it is unobtrusive during daily activity. The S-Patch ExL continuously acquires ECG signals and wirelessly transmits the data and via a smartphone application (that meets the definition of MDDS) to a compatible 3rd-party cloud-based ECG viewing platform for further analysis and interpretation by qualified medical professionals. The S-Patch ExL does not include but works with 3rd-party lithium coin batteries and 3rd-party ECG electrodes.
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    K Number
    K231289
    Device Name
    S-Patch Ex Wearable ECG Patch
    Manufacturer
    Wellysis Corp.
    Date Cleared
    2023-08-30

    (118 days)

    Product Code
    DSH
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wellysis Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    S-Patch Ex wearable ECG patch is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. S-Patch Ex wearable ECG patch is intended for use by patients 18 years or older.
    Device Description
    The S-Patch Ex ECG Patch System ("S-Patch Ex") is a light-weight electrocardiogram ("ECG") data collection device. The S-Patch Ex operates wirelessly, and due to its compact size, it is unobtrusive during daily activity. The S-Patch Ex continuously acquires ECG signals and wirelessly transmits the data and via a smartphone application (that meets the definition of MDDS) to a compatible 3rd-party cloud-based ECG viewing platform for further analysis and interpretation by qualified medical professionals. The S-Patch Ex does not include but works with 3rd-party lithium coin batteries and 3rd-party ECG electrodes.
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