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510(k) Data Aggregation

    K Number
    K192724
    Device Name
    Propeller Sensor for Symbicort
    Manufacturer
    Reciprocal Labs Corporation
    Date Cleared
    2020-03-26

    (181 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Reciprocal Labs Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Propeller System includes the Propeller Sensor Model 2018-S. The sensor is an accessory device intended for singlepatient use to assist physicians and patients in recording and monitoring the actuations of prescribed pMDI usage for the Symbicort device. The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the pMDI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician, and healthcare providers. The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their pMDI and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians, and health care providers. When used with a prescribed pMDI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing pMDI technique. The Propeller System is intended to be used in populations from Child (>2 years) to Adult. The Propeller System can be used both indoors; home, work, and clinical settings, as well as on aircraft. The Propeller System may also be used in clinical trials where researchers need to know information about the use of pMDI medication(s) by a participant. The output of the Propeller System is not intended to diagnosis provided by a licensed physician. The Propeller System is not intended for use as an pMDI dose counter, nor is it intended to indicate the quantity of medication remaining in an pMDI.
    Device Description
    Pressurized Metered Dose Inhaler (pMDI) / Symbicort Accessory that monitors inhaler usage. The portable sensor mounts to the back of the pMDI and records inhalation events when the inhaler is used.
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    K Number
    K180770
    Device Name
    Propeller Sensor for Neohaler
    Manufacturer
    Reciprocal Labs Corporation
    Date Cleared
    2018-08-01

    (131 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Reciprocal Labs Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Propeller System includes the Propeller Sensor Model 2017-B. The sensor is an accessory device intended for singlepatient use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for the Neohaler and Breezhaler devices. The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the DPI sensor, and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician, and healthcare providers. The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their DPI and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians, and health care providers. When used with a prescribed DPI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing DPI technique. The Propeller System is intended to be used in populations from Child (>2 years) to Adult. The Propeller System can be used both indoors home, work, and clinical settings, as well as on aircraft. The Propeller System may also be used in clinical trials where researchers need to know information about the use of DPI medication(s) by a participant. The output of the Propeller System is not intended to diagnosis provided by a licensed physician. The Propeller System is not intended for use as an DPI dose counter, nor is it intended to indicate the quantity of medication remaining in an DPI.
    Device Description
    Dry Powder Inhaler (DPI) / Neohaler Accessory that monitors inhaler usage. The portable sensor mounts on top of a DPI and records inhalation events when the inhaler is used.
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    K Number
    K161454
    Device Name
    Propeller Sensor Model 2015-E
    Manufacturer
    Reciprocal Labs Corporation
    Date Cleared
    2016-11-01

    (159 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Reciprocal Labs Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Propeller System includes the Propeller Sensor is an accessory device intended for singlepatient use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for the Ellipta devices. The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the DPI sensor, and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician, and healthcare providers. The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their DPI and its use, to capture other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians, and health care providers. When used with a prescribed DPI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing DPI technique. The Propeller System is intended to be used in populations from Child (>2 years) to Adult. The Propeller System can be used both indoors home, work, and clinical settings, as well as on aircraft. The Propeller System may also be used in clinical trials where researchers need to know information about the use of DPI medication(s) by a participant. The output of the Propeller System is not intended to diagnosis provided by a licensed physician. The Propeller System is not intended for use as an DPI dose counter, nor is it intended to indicate the quantity of medication remaining in an DPI.
    Device Description
    Dry Power Inhaler (DPI) / Ellipta Accessory that monitors a patient's inhaler usage. The portable, polycarbonate sensor clips on top of a DPI mouthpiece cover and passively records inhalation events when the inhaler is used using infra-red (IR) sensors. The sensor then sends the event information via Bluetooth to the mobile phone or wireless gateway.
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    K Number
    K142516
    Device Name
    Propeller System
    Manufacturer
    RECIPROCAL LABS CORPORATION
    Date Cleared
    2015-05-15

    (249 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    RECIPROCAL LABS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Propeller System includes the Propeller MDI Model 2 OTC Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage. The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the MDI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers. The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their respiratory medication(s) and its use, to capture other patientreported information and outcomes, and to allow that information to be shared with their caregivers, physicians and health care providers. When used with a prescribed MDI, the system can report on information captured during the normal course of use, such as the time between actuations that can be helpful in assessing MDI technique. When used under the care of a physician with a prescribed MDI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to MDI or other inhaled medications through the use of feedback such as reminders and notifications, and self-management education. The Propeller System is intended to be used in populations from used in populations from Child (>2 years) to adult. The Propeller system can be used both indoors; home, work and clinical settings, as well as on aircraff. The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI or other inhaled medication(s) by a participant. The output of the Propeller System is not intended to diagnose provided by a licensed physician. The Propeller System is not intended for use as an MDI or inhaled medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI or inhaled medication.
    Device Description
    The Propeller System includes the Propeller MDI Model 2 OTC Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage. The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the MDI sensor, and report and review symptoms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers. The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their respiratory medication(s) and its use, to capture other patientreported information and outcomes, and to allow that information to be shared with their caregivers, physicians and health care providers.
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    K Number
    K140638
    Device Name
    PROPELLER SYSTEM - MODEL 2
    Manufacturer
    RECIPROCAL LABS CORPORATION
    Date Cleared
    2014-05-02

    (51 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    RECIPROCAL LABS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Propeller System includes the Propeller MDI Model 2 Sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage. The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual user entry, to a remote storage system. With the Propeller Mobile Application the user can review information collected from the MDI sensor, and review symploms and other information about their disease management and its impact. The user may also share their information with their caregivers, physician and healthcare providers. The Propeller Web Application is software that, like the Propeller Mobile Application, is intended to allow users to review the collected information and characteristics of their MDI and its use, to caplure other patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and health care providers. When used under the care of a physician with a prescribed MDI, the system can report on information caplured during the normal course of use, such as the lime between actualions that can be helpful in assessing MDI technique. When used under the care of a physician will a prescribed MDI, the system can be used to reduce the frequency of respiratory health symploms and exacerbations by increasing adherence to MDI medications through the use of feedback such as reminders and notifications, and self-management education. The Propeller System is intended to be used in populations from Child (>2 years) to adult." The Propeller system can be used both indoors and ouldoors; home, work and clinical settings, as well as on aircraft. The Propeller System may also be used in clinical trials where researchers need to know information about the use of MDI medication(s) by a participant. The Propeller System is not inlended to diagnose or replace a diaonosis provided by a licensed physician. The Propeller System is not intended for use as an MDI dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI.
    Device Description
    Electronic MDI Accessory
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    K Number
    K121609
    Device Name
    ASTHMAPOLIS SYSTEM
    Manufacturer
    RECIPROCAL LABS CORPORATION
    Date Cleared
    2012-07-02

    (31 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    RECIPROCAL LABS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Asthmapolis System includes the Asthmapolis Sensor which is an electronic accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage. The Asthmapolis Mobile Application records, stores, and transmits usage events from the Asthmapolis Sensor to a remote storage system. The Asthmapolis Web Application is software intended to allow users to review the collected information and characteristics of MDI use, to add detail associated with a recorded usage event, and to share that information with their physician in order to provide additional information associated with the condition for which their MDI medication(s) are prescribed. The Asthmapolis System may also be used in clinical trials where researchers need to know information about use of a MDI Medication(s) by a participant. The output of the Asthmapolis System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Asthmapolis system is not intended for use as a MDI medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI.
    Device Description
    Electronic MDI Accessory
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