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The Strive™ Dual Zone PFM is a monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation maneuver. The device will monitor the PEF of patients whose doses of medication are dependent upon a measured obstruction in PEF. The Strive™ Peak Flow Meter is designed for children five years or older and adults. The intended environments for use include home, hospitals and clinics.

The Strive™ Dual Zone Peak Flow Meter (PFM) is a hand-held monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation mancuver. It can be used to objectively measure PEF by tracking day-to-day changes in breathing patterns. The Strive™ PFM meets the Standards of Spirometry, 2005 revision, for portable peak flow meters as established by the American Thoracic Society and also meets ISO23747, First edition 2007-07-15, for Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans. The Strive™ PFM and product insert meets the educational guidelines recommended by the National Asthma Educational Prevention Program (NAEPP) of the National Institutes of Health. The Strive™ PFM has two scale ranges to make the device suitable for both pediatric (+5 yrs) and adult patients who use a peak flow meter as part of their treatment program for respiratory conditions. A range selector is used to select the scale that best fits the patient's needs as determined by a healthcare provider. The device incorporates the NAEPP three zone color codes. The color-coded zone indicators on the side of the device adjust to define the patient's red, yellow and green zones. They can be readjusted as recommended by a healthcare provider.

The TruPeak® Peak Flow Meter (PFM) is a portable monitoring device that measures the peak expiratory flow (PEF) generated by a patient during a forced exhalation maneuver. This measurement is useful in detecting changes that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma and emphysema. This device is packaged and labeled so it can be used as a screening device in a hospital or other clinical setting. Labeling is also included for the use of the device if dispensed by a health care provider to a patient for personal use.

The TruPeak® Peak Flow Meter (PFM) is a portable monitoring device that measures the peak expiratory flow (PEF) generated by a patient during a forced exhalation maneuver.

The TruZone™ Peak Flow Meter (PFM) is a portable monitoring device that measures the peak expiratory flow (PEF) generated by a patient during a forced exhalation maneuver. This measurement is useful in detecting changes in airways that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma and emphysema. This device is packaged and labeled so it can be used as a screening device in a hospital or other clinical setting. Labeling is also included for the use of the device if dispensed by a health care provider to a patient for personal use.

The TruZone™ Peak Flow Meter (PFM) is a portable monitoring device that measures the peak expiratory flow (PEF) generated by a patient during a forced exhalation maneuver.

Collapsible Holding Chamber used as an accessory to administer meter dose inhalers to patients being mechanically ventilated.

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Portable monitoring device which measures the peak expiratory flow (PEF) generated by the patient during a forced exhalation maneuver. This measurement is useful in detecting changes in airways that could signal a worsening of symptoms or an improvement in breathing function for people with respiratory conditions such as Asthma or emphysema.

TruZone™ Peak Flow Meter

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The AeroGear Asthma Action Kit is a product containing the AeroChamber Aerosol Holding Chamber, a TruZone Peak Flow Meter, and educational materials used in an asthma management program. This kit is intended to be marketed to hospitals, outpatient clinics and physicians.

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The TruZone Peak Flow Meter is a simple mechanical device that responds to and indicates the Peak Expiratory Flow Rate (PEFR) generated by the user during a forced exhalation maneuver. inlet of the device is placed into the user's The mouth after which the maximum rate at exhalation is attempted from nearly full lungs. As this forced exhalation commences an internal piston extends ત્વ spring as reaction to an internal pressure spike. An indicator is pushed by the moving piston and remains at the maximum displacement position of the piston after the maneuver is terminated. This position corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. piston displacement function is logarithmic The thereby providing greater resolution of scale at lower PEFR readings. The TruZone Peak Flow Meter is identical in form and function to the TruZone Peak Flow Meter as described in its 510(k) #926307 except for changes in component dimensions necessary for the performance of the device to conform to the November 1994 ATS Standards update.

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The TruPeak Peak Flow Meter is a simple mechanical that responds to and indicates the Peak device Expiratory Flow Rate (PEFR) generated by the user during a forced exhalation maneuver. inlet of the device is placed into the user 's The mouth after which the maximum rate at exhalation is attempted from nearly full lungs. As this forced commences an internal piston extends exhalation spring as reaction to an internal pressure spike. An indicator is pushed by the moving piston and remains position of the the maximum displacement piston at maneuver is terminated. This position after the corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. displacement function is logarithmic The piston thereby providing greater resolution of scale at lower PEFR readings.

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The TruPeak Peak Flow Meter is a simple mechanical device that responds to and indicates the Peak Expiratory Flow Rate (PEFR) generated by the user during a forced exhalation maneuver. inlet of the device is placed into the user's The mouth after which the maximum rate at exhalation is attempted from nearly full lungs. As this forced exhalation commences an internal piston extends a spring as reaction to an internal pressure spike. An indicator is pushed by the moving piston and remains at the maximum displacement position of the piston after the maneuver is terminated. This position corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. The The piston displacement function is logarithmic thereby providing greater resolution of scale at lower PEFR readings. The TruPeak Peak Flow Meter is identical in form and function to the TruZone Peak Flow Meter as described in its 510(k) #926307 except for the use of zone management tapes. The essence of the modification to this 510(k) is changes in the device labeling to conform to the "Guidance for labeling Peak Flow Meters for Over the Counter Sale", dated June 1993.

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The Truzone Peak Flow Meter is a simple mechanical that responds to and indicates the Peak device Expiratory Flow Rate (PEFR) generated by the user during a forced exhalation maneuver. inlet of the device is placed into the user's The mouth after which the maximum rate at exhalation is attempted from nearly full lungs. forced As this exhalation commences an internal piston extends a spring as reaction to an internal pressure spike. An indicator is pushed by the moving piston and remains the maximum displacement position of the piston at maneuver is terminated. This position the after corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. piston displacement function is logarithmic The thereby providing greater resolution of scale at lower PEFR readings. The TruZone Peak Flow Meter is identical in form and function to the TruZone Peak Flow Meter as described in its 510(k) #926307 except for the addition of a separate package of Colorione tapes as an accessory to the TruZone Peak Flow Meter. The essence of the modification to this 510 (k) is adding the package for sale to aforementioned accessory physicians.