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The D R Burton iPEP Therapy System or vPEP is intended for use as a Positive Expiratory Pressure (PEP) by patients capable of generating an exhalation flow of 10 lpm for 3-4 seconds and an Incentive Spirometer as an inspiratory, deep breathing positive exerciser. Intended for single-patient, multi-use. iPEP System for hospital and clinical settings vPEP for hospital, clinical, and home care setting

D R Burton Healthcare as indicated above proposes to offer 2 devices which we will refer to as the: - iPEP (integrated Incentive spirometer with PEP) system and ● - . vPEP which is a standalone PEP therapy device #### iPEP system - Volumetric Incentive Spirometer up to 4000 cc - Oscillatory PEP module (cartridge) ● The design of the iPEP system permits the PEP cartridge to be removed and used as an independent PEP device, which we refer to as the Pocket PEP. In order to use the Pocket PEP the iPEP system includes a separate mouthpiece, carrying / storage case and dust cover which are needed when one wants to use the PEP cartridge independent of the iPEP systems (Pocket PEP). When the PEP cartridge is removed from the iPEP system, one can insert a cover where the PEP cartridge has been removed to allow the incentive spirometer to be used one its own. #### vPEP - The vPEP is the standalone device that is pre-assembled and is not intended to be used in the iPEP ● System. The vPEP incorporates the identical internal components of the PEP cartridge of the iPEP system.