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RECIPROCAL LABS CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30096378143009637814RECIPROCAL LABS CORPORATION1N2020-04-25One South Pinckney Street Suite 610 Madison WI US 53703

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1432531844774710K192724Propeller Sensor for SymbicortCAF2020-03-26
1432531867246571K180770Propeller Sensor for NeohalerCAF2018-08-01
1432531229758169K161454Propeller Sensor Model 2015-ECAF2016-11-01
1432531509096733K152882Propeller SystemCAF2016-03-08
1432531650458231K152482Propeller Sensor Model 2014-RCAF2016-03-04
1432531308478862K143671Propeller Model 2014-D SensorCAF2015-06-19
1432531499438838K142960Propeller System 2014-RCAF2015-03-05
1432531391115540K142516Propeller SystemCAF2015-05-15
1432531514582130K140638PROPELLER SYSTEM - MODEL 2CAF2014-05-02
1432531999422192K121609ASTHMAPOLIS SYSTEMCAF2012-07-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAF102020-03-26

PMN#

GUDID#

Propeller - The Propeller System includes the Propeller Sensor Model 2018-S. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed pMDI usage for theSymbicort device.The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual userentry, to a remote storage system. With the Propeller Mobile Application the user can review information collected fromthe 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 toreview the collected information and characteristics of their pMDI and its use, to capture other patient-reportedinformation and outcomes, and to allow that information to be shared with their caregivers, physicians, and health careproviders.When used with a prescribed pMDI, the system can report on information captured during the normal course of use, suchas 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 and outdoors; 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 ofpMDI medication(s) by a participant.The output of the Propeller System is not intended to diagnose or replace a 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 ofmedication remaining in an pMDI.

RECIPROCAL LABS CORPORATION

2021-05-26

Propeller - Model 2017-B. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for Neohaler® 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 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 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 and outdoors; 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 diagnose or replace a 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.

RECIPROCAL LABS CORPORATION

2018-09-11

Propeller - The Propeller System includes the Propeller MDI Model 2 OTC Sensor. The 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 patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and healthcare 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 Child (>2 years) to adult.The Propeller System can be used both indoors and outdoors; 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 or other inhaled medication(s) by a participant.

RECIPROCAL LABS CORPORATION

2016-07-22

Propeller - The Propeller System includes the Propeller SMI Model 2014-R Sensor. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed SMI 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 SMI 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 patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and healthcare providers.When used with a prescribed SMI, 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 SMI technique.When used under the care of a physician with a prescribed SMI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to SMI 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 Child (>2 years) to adult.The Propeller System can be used both indoors and outdoors; 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 or other inhaled medication(s) by a participant.

RECIPROCAL LABS CORPORATION

2016-07-22

Propeller - The Propeller System includes the Propeller DPI Model 2014-D Sensor. The sensor is an accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed DPI 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 DPI 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 patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and healthcare 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.When used under the care of a physician with a prescribed DPI, or other inhaled medication, the system can be used to reduce the frequency of respiratory health symptoms and exacerbations by increasing adherence to DPI 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 Child (>2 years) to adult.The Propeller System can be used both indoors and outdoors; 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 or other inhaled medication(s) by a participant.

RECIPROCAL LABS CORPORATION

2016-07-22

Propeller - The Propeller System includes the Propeller Sensor Model 2015-E. The sensor is an accessory device intended for singlepatientuse to assist physicians and patients in recording and monitoring the actuations of prescribed DPI usage for theEllipta devices.The Propeller Mobile Application records, stores, and transmits usage events from Propeller Sensors, or via manual userentry, to a remote storage system. With the Propeller Mobile Application the user can review information collected fromthe DPI 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 toreview the collected information and characteristics of their DPI and its use, to capture other patient-reported informationand 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 asthe 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 and outdoors; 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 DPImedication(s) by a participant.The output of the Propeller System is not intended to diagnose or replace a 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 ofmedication remaining in an DPI.

RECIPROCAL LABS CORPORATION

2017-01-16

Propeller - The Propeller System includes the OTC Sensor Model 2016-M for MDI. The 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 patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and healthcare 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 Child (>2 years) to adult.The Propeller System can be used both indoors and outdoors; 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 or other inhaled medication(s) by a participant.

RECIPROCAL LABS CORPORATION

2017-12-21

Propeller - The Propeller System includes the OTC Sensor Model 2016-M for MDI. The 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 patient-reported information and outcomes, and to allow that information to be shared with their caregivers, physicians and healthcare 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 Child (>2 years) to adult.The Propeller System can be used both indoors and outdoors; 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 or other inhaled medication(s) by a participant.

RECIPROCAL LABS CORPORATION

2017-12-21