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510(k) Data Aggregation

    K Number
    K231274
    Device Name
    Natural Cycles
    Date Cleared
    2023-08-24

    (114 days)

    Product Code
    Regulation Number
    884.5370
    Why did this record match?
    Applicant Name (Manufacturer) :

    Natural Cycles Nordic AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Natural Cycles is a stand-alone software application, intended for women 18 years and older, to monitor their fertility. Natural Cycles can be used for preventing a pregnancy (contraception) or planning a pregnancy (conception).
    Device Description
    Natural Cycles is an over-the-counter web and mobile-based standalone software application that monitors a woman's menstrual cycle using information entered by the user and informs the user about her past, current, and future fertility status. The following information is used by the Natural Cycles software: - daily body temperature measurements - information about the user's menstruation cycle (i.e., start date, number of days) - optional ovulation or pregnancy test results A proprietary algorithm evaluates the data and returns the user's fertility status. Natural Cycles is available in three modes: Contraception (NC° Birth Control), Conception (NC° Plan Pregnancy), and Pregnancy (NCº Follow Pregnancy). For NCº Birth Control mode, the device provides predictions of "not fertile," shown as green days, and "use protection," shown as red days, that allow the user to determine the days on which her risk of conception is highest, and then make choices about either abstaining from sex or using a barrier method of contraception to prevent pregnancy. In addition to measuring daily basal body temperature with an oral thermometer with two decimal points, the predicate submission cleared the Oura Ring for automatic temperature input to the Natural Cycles algorithm, and the current submission expands to allow the device to utilize automatic temperature inputs from the Apple Watch. Natural Cycles can be used by women 18 years and older. Women who have been on hormonal birth control within 60 days prior to using Natural Cycles have a higher risk of becoming pregnant when compared to women who have not been on hormonal birth control within the 12 months prior to using the device may not be right for women who have a medical condition where pregnancy would be associated with a significant risk to the mother or the fetus.
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    K Number
    K202897
    Device Name
    Natural Cycles
    Date Cleared
    2021-06-24

    (268 days)

    Product Code
    Regulation Number
    884.5370
    Why did this record match?
    Applicant Name (Manufacturer) :

    Natural Cycles Nordic AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Natural Cycles is a stand-alone software application, intended for women 18 years and older, to monitor their fertility. Natural Cycles can be used for preventing a pregnancy (contraception) or planning a pregnancy (conception).
    Device Description
    Natural Cycles is an over-the-counter web and mobile-based standalone software application that monitors a woman's menstrual cycle using information entered by the user and informs the user about her past, current and future fertility status. The following information is used by the Natural Cycles software: - daily body temperature measurements - information about the user's menstruation cycle (i.e., start date, number of days) - optional ovulation or pregnancy test results A proprietary algorithm evaluates the data and returns the user's fertility status. Natural Cycles is available in three modes: Contraception, and Pregnancy. For Contraception mode, the device provides predictions of "not fertile," shown as green days, and "use protection," shown as red days, that allow the user to determine the days on which her risk of conception is highest, and then make choices about either abstaining from sex or using a barrier method of contraception to prevent pregnancy. In addition to measuring daily basal body temperature with an oral thermometer with two decimal points, the device allows automatic temperature input from the Oura ring, a wearable temperature monitor. Natural Cycles can be used by women 18 years and older. Women who have been on hormonal birth control within 60 days prior to using Natural Cycles have a higher risk of becoming preqnant when compared to women who have not been on hormonal birth control within the 12 months prior to using the device may not be right for women who have a medical condition where pregnancy would be associated with a significant risk to the mother or the fetus.
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    K Number
    DEN170052
    Device Name
    Natural Cycles
    Date Cleared
    2018-08-10

    (324 days)

    Product Code
    Regulation Number
    884.5370
    Why did this record match?
    Applicant Name (Manufacturer) :

    Natural Cycles Nordic AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Natural Cycles is a stand-alone software application, intended for women 18 years and older, to monitor their fertility. Natural Cycles can be used for preventing a pregnancy (contraception) or planning a pregnancy (conception).
    Device Description
    Natural Cycles is an over-the-counter web and mobile-based standalone software application that monitors a woman's menstrual cycle using information entered by the user and informs the user about her past, current and future fertility status. The following information is entered into the application by the user: - daily basal body temperature (BBT) measurements - information about the user's menstruation cycle (i.e., start date, number of days) - optional ovulation or pregnancy test results A proprietary algorithm evaluates the data and returns the user's fertility status.
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