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The Hailie® sensor is intended for single-patient multiple use in the home environment as an electronic data capture accessory for monitoring and recording actuation, inspiratory flow and inhaler shake for prescribed inhaler usage. The Hailie® sensor may be used in the following applications: in clinical trials, where specialists, general practitioners, nurses, and educators need to know if a patient has used their prescribed medication, or assess inspiratory flow and inhaler technique; and in patient self-management. The Hailie® sensor is compatible only with the Teva HFA MDIs like ProAir, Albuerol Sulphate inhalers. The Hailie® sensor is not intended to indicate remaining quantity of medication in an inhaler and does not include a dose counting function. The Hailie® sensor is not intended to provide spirometry measurements.

The subject device Hailie® Sensor (Hailie® sensor) NF0110 model, is a modification to the Hailie® sensor NF0109 model (the predicate device) and is used to provide medication actuation monitoring, shake and airflow recording functions, for use as an accessory to the inhaler specified on the device label. The Hailie® sensor is indicated for use only with the following TEVA MDIs: ProAir® HFA & Albuterol Sulphate HFA. The Hailie sensor NF0110 is a clip-on device that attaches externally around the housing of the inhaler. The optical sensor and induction coil sensor are used to detect the inhaler presence and monitor actuation. Motion and flow sensors are used to record inhaler usage technique parameters. The Haile sensor contains an electronic clock and calendar that are used to log the date and time of inhaler usage events. The user interface consists of a single Status Button and a multi-color LED indicator to check device status and initiate communications functions. The Hailie sensor has a Bluetooth interface to wirelessly exchange medication usage data with a paired communications device and compatible mobile software applications.

The Hailie@ sensor is intended for single-patient multiple use in the home environment as an electronic data capture accessory for monitoring and recording actuation, inspiratory flow and inhaler shake for prescribed inhaler usage. The Hailie® sensor may be used in the following applications: in clinical trials, where specialists, general practitioners, nurses, and educators need to know if a patient has used their prescribed medication, or assess inspiratory flow and inhaler technique; and in patient self-management including medication reminders. The Hailie@ sensor is compatible only with the Ventolin, Advair, Flovent inhaler. The Hailie® sensor is not intended to indicate remaining quantity of medication in an inhaler and does not include a dose counting function. The Hailie® sensor is not intended to provide spirometry measurements.

The Hailie® sensor is intended for single-patient multiple use in the home environment as an electronic data capture accessory for monitoring and recording actuation, inspiratory flow and inhaler shake for prescribed inhaler usage.

The Hailie@ sensor is intended for single patient, multiple use, in the home environment, as an electronic data capture accessory for monitoring and recording actuations, inspiratory flow, and inhaler orientation, for prescribed inhaler usage. The Hailie@ sensor may be used in the following applications: in clinical trials, where specialists, general practitioners, nurses, and educators need to know if a patient has used their prescribed medication or assess inspiratory flow and inhaler technique; and in patient self-management including medication reminders. The Hailie® sensor is compatible only with the following ELLIPTA® DPI inhalers: Breo™, Incruse™, Trelegy™ and Arnuity™. The Hailie@sensor is not intended to indicate remaining quantity of medication in an inhaler and does not include a dose counting function. The Hailie® sensor is not intended to provide spirometry measurements.

The Hailie® Sensor (Hailie® sensor) NF0106 model, is a modification to the Hailie® sensor NF0109 model, and is used to provide medication reminder, actuation monitoring, orientation and airflow recording functions, for use as an accessory to the inhaler specified on the device label. The Haili® sensor is indicated for use only with the following ELLIPTA® DPI inhalers: Breo™, Anoro™, Incruse™, Trelegy™ and Arnuity™. The Hailie® sensor is a clip-on device that attaches externally around the housing of the inhaler. Optical sensors are used to detect the inhaler presence and monitor actuation. Motion and flow sensors are used to record inhaler usage technique parameters. The Hailie® sensor contains an electronic clock and calendar that are used to log the date and time of inhaler usage events. The user interface consists of a single Status Button and a multi-color LED indicator to check device status, initiate communications functions, and provide reminder features. The Hailie® sensor has a Bluetooth interface to wirelessly exchange medication usage data and reminder setting data with a paired communications device and compatible mobile software applications.

The Hailie® sensor is intended for single-patient use in the home environment as an electronic data capture accessory for monitoring and recording actuations, inspiratory flow, and inhaler shake, for prescribed inhaler usage. The Hailie® sensor may be used in the following applications: in clinical trials, where specialists, general practitioners, nurses, and educators need to know if a patient has used their prescribed medication, or assess inspiratory flow and inhaler technique; and in patient self-management including medication reminders. The Hailie® sensor is compatible only with the Symbicort™ MDI inhaler. The Haile® sensor is not intended to indicate remaining quantity of medication in an inhaler and does not include a dose counting function. The Hallie® sensor is not intended to provide spirometry measurements.

The Hailie® sensor is a modification to the SmartTouch sensor, and is used to provide medication reminder, actuation monitoring, and shake and airflow recording for use as an accessory to the inhaler specified on the device label. The Hailie® sensor is indicated for use only with the Symbicort™ MDI inhaler. The Hailie® sensor is a clip-on device that attaches externally around the housing of the inhaler. Mechanical and optical sensors are used to detect the inhaler presence and monitor actuation. Motion and flow sensors are used to record inhaler usage technique parameters. The Hailie® sensor contains an electronic clock and calendar that are used to log the date and time of inhaler usage events. The user interface consists of a single Status Button and a multi-color LED indicator to check device status, initiate communications functions, and provide reminder features. The Hailie® sensor has a Bluetooth interface to wirelessly exchange medication usage data and reminder setting data with a paired communications device and compatible mobile software applications.

The Hailie™ sensor is intended for single-patient use in the home environment as a medication reminder and electronic data capture accessory for recording usage of prescribed inhaler medication. This may be used in the following applications: · In clinical trials, where researchers need to know when a patient has used their trial inhaler medication. · In clinical practice, where specialists, general practitioners, nurses, and educators need to know if a patient has used their prescribed inhaler medication. · In self-management, where patients need to track their medication use as part of their management plan. The Hailie™ sensor is compatible only with the HandiHaler® inhaler and is for use by adults.

The Hailie™ sensor is used to provide a medication reminder and actuation recording function for use as an accessory to the inhaler specified on the device label. Under the current 510(k), the Hailie™ sensor is indicated for use only with the HandiHaler® inhaler. The Hailie™ sensor is a clip-on device that attaches externally around the housing of the inhaler. Mechanical, optical and acoustic sensors are used to detect the presence and actuation of the inhaler. The Hailie™ sensor contains an electronic clock and calendar that are used to log the date and time of inhaler actuation. The user interface consists of a single Status Button and dual multi-color LED indicators to check device status, initiate communications functions, and provide reminder features. The Hailie™ sensor has a Bluetooth interface to wirelessly exchange medication and reminder setting data with a paired communications device and compatible mobile software applications.

The Hailie™ sensor is intended for single-patient use in the home environment as a medication reminder and electronic data capture accessory for recording usage of prescribed inhaler medication. This may be used in the following applications: · In clinical trials, where researchers need to know when a patient has used their trial inhaler medication. · In clinical practice, where specialists, general practitioners, nurses, and educators need to know if a patient has used their prescribed inhaler medication. · In self-management, where patients need to track their medication use as part of their management plan. The Hailie™ sensor is compatible only with the Advair® Diskus® inhalers. The Hailie™ sensor is not intended to indicate remaining quantity of medication in an inhaler and does not include a dose counting function.

The Hailie™ sensor is used to provide a medication reminder and usage recording function as an accessory to the inhalers specified on the device label. Under the current 510(k), the Hailie™ sensor is indicated for use only with the Advair® Diskus® (100/50, 250/50, 500/50 mcg) and Flovent® Diskus® (50, 100, 250 mcg) inhalers. The Hailie™ sensor is a clip-on device that attaches externally around the housing of the inhaler. Optical sensors are used to detect the presence and usage of the inhaler. The Hailie™ sensor contains an electronic clock and calendar that are used to log the date and time of inhaler usage. The user interface consists of a three control buttons and three LED indicators to check device status, initiate communications functions, and provide reminder features. The Hailie™ sensor has a Bluetooth interface to wirelessly exchange medication usage and reminder setting data with a paired communications device and compatible mobile software applications.

The Hailie™ sensor is intended for single-patient use in the home environment as a medication reminder and electronic data capture accessory for recording actuations of prescribed inhaler usage. This may be used in the following applications: - In clinical trials, where researchers need to know when a patient has actuated their trial inhaler medication. • In clinical practice, where specialists, general practitioners, nurses, and educators need to know if a patient has actuated their prescribed inhaler medication. • In self-management, where patients need to track their medication use as part of their management plan. The Hailie™ sensor is compatible only with Bevespi Aerosphere® and is for use by adults. The Hailie™ sensor is not intended to indicate remaining quantity of medication in an inhaler and does not include a dose counting function.

The Hailie™ sensor is used to provide a medication reminder and actuation recording function for use as an accessory to the inhaler specified on the device label. Under the current 510(k), the Hailie™ sensor is indicated for use only with the Bevespi Aerosphere®. The Hailie™ sensor is a clip-on device that attaches externally around the housing of the inhaler. Optical and mechanical sensors are used to detect the presence and actuation of the inhaler. The Hailie™ sensor contains an electronic clock and calendar that are used to log the date and time of inhaler actuation. The user interface consists of three control buttons and three LED indicators to check device status, initiate communications functions, and provide reminder features. The Hailie™ sensor has a Bluetooth interface to wirelessly exchange medication and reminder setting data with a paired communications device and compatible mobile software applications.

The Smartinhaler™ is intended for single-patient use in the home environment as a medication reminder and electronic data capture accessory for recording actuations of prescribed MDI usage. This may be used in the following applications: · In clinical trials, where researchers need to know when a patient has actuated their trial MDI medication. · In clinical practice, where specialists, general practitioners, nurses, and educators need to know if a patient has actuated their prescribed MDI medication. · In self-management, where patients need to track their medication use as part of their management plan. The Smartinhaler™ is compatible only with the following MDIs: Ventolin® HFA, Flovent® HFA, ProAir® HFA, and QVAR® HFA. The intended MDI is specified on the product labeling. The Smartinhaler™ is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function.

Smartinhaler™ is used to provide a medication reminder and actuation recording function for use as an accessory with a Metered Dose Inhaler (MDI) as part of normal daily use of the MDI. Smartinhaler™ is a clip-on device that attaches externally around the housing of an MDI. The Smartinhaler™ comes in rechargeable and non-rechargeable models. Each Smartinhaler™ is compatible only with one of the following MDIs: Ventolin® HFA (90 mcg), Advair® HFA (45/21, 115/21, 230/21 mcg), Flovent® HFA (44, 110, 220 mcg), ProAir® HFA (90 mcg), QVAR® HFA (40, 80 mcg). The intended MDI is indicated on the device labeling. Optical and pressure sensors are used to detect MDI presence and actuation, and the device logs the usage history of the MDI. The Smartinhaler™ contains an electronic clock and calendar that is used to log the date and time of MDI actuation. The Smartinhaler™ user interface consists of one LED indicator and one control button to check device status, initiate communications functions, and cancel medication reminders. The Smartinhaler™ has a Bluetooth interface to wirelessly exchange medication and reminder setting data with a paired communications device and compatible mobile software applications.

The Smart Touch is intended for single-patient use in the home environment as a medication reminder and electronic data capture accessory for recording actuations of prescribed MDI usage. This may be used in the following applications: · In clinical trials, where researchers need to know when a patient has actuated their trial MDI medication: · In clinical practice, where specialists, general practitioners, nurses, and educators need to know if a patient has actuated their prescribed MDI medication. · In self-management, where patients need to track their medication use as part of their management plan. The SmartTouch is compatible only with the Symbicort MDI. The SmartTouch is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function.

SmartTouch is used to provide a medication reminder and actuation recording function for use as an accessory with a Metered Dose Inhaler (MDI) as part of normal daily use of the MDI. SmartTouch is a clip-on device that attaches externally around the housing of an MDI. SmartTouch is compatible only with the Symbicort MDI. Optical and mechanical sensors are used to detect MDI presence and actuation, and the device logs the usage history of the MDI. The SmartTouch contains an electronic clock and calendar that is used to log the date and time of MDI actuation. The SmartTouch user interface consists of two LED indicators and three control buttons to check device status, initiate communications functions, and provide reminder features. The SmartTouch has a Bluetooth interface to wirelessly exchange medication and reminder setting data with a paired communications device and compatible mobile software applications.

The Smart Touch is intended for single-patient use in the home environment as a medication reminder and electronic data capture accessory for recording actuations of prescribed MDI usage. This may be used in the following applications: · In clinical trials, where researchers need to know when a patient has actuated their trial MDI medication; · In clinical practice, where specialists, general practitioners, nurses, and educators need to know if a patient has actuated their prescribed MDI medication. · In self-management, where patients need to track their medication use as part of their management plan. The SmartTouch is compatible only with the Symbicort MDI. The SmartTouch is not intended to indicate remaining quantity of medication in an MDI and does not include a dose counting function.

SmartTouch is used to provide a medication reminder and actuation recording function for use as an accessory with a Metered Dose Inhaler (MDI) as part of normal daily use of the MDI. SmartTouch is a clip-on device that attaches externally around the housing of an MDI. SmartTouch is compatible only with the Symbicort MDI. Optical and mechanical sensor methods are used to detect MDI presence and actuation, and the device logs the usage history of the MDI. The SmartTouch contains an electronic clock and calendar that is used to log the date and time of MDI actuation. The SmartTouch user interface consists of two LED indicators and three control buttons to check device status, initiate communications functions, and provide reminder features. The SmartTouch has a Bluetooth interface to wirelessly exchange medication and reminder setting data with a paired communications device and compatible mobile software applications.