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The Luna® G3 BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The integrated humidification and warming of air from the flow generator device. These devices are intended for single-patient use by prescription in the home or hospital/ institutional environment on adult patients. It is to be used on patients > 66 lbs / 30 kg for whom CPAP therapy has been prescribed.

The Luna® G3 BPAP system is a microprocessor controlled, blower-based system that generates positive airway pressure to support treatment of obstructive sleep apnea. Its hardware design is identical to the previously cleared Luna® G3 BPAP 25A (K201620). The subject device includes two models, with different pressure ranges. They both have four therapy modes, which are CPAP, Spontaneous (S), Timed (T) and Spontaneous/Timed (S/T).

The Luna® G3 BPAP 25A is a Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The integrated humidification and warming of air from the flow generator device. These devices are intended for single-patient use by prescription in the home or hospital/ institutional environment on adult patients. If is to be used on patients >66lbs/30kg for whom CPAP therapy has been prescribed. The system can deliver bi-level therapy or auto bi-level therapy.

The Luna® G3 BPAP 25A is a microprocessor controlled, blower-based system that generates bi-level positive airway pressure (IPAP/EPAP) to support treatment of obstructive sleep apnea. The system provides fixed or auto-adjust pressure from 4 to 25 cmH2O above the ambient atmospheric pressure to a patient's oral/nasal airway.

iCodeConnect, in conjunction with a Luna CPAP or Auto-CPAP device, is intended for use in treating obstructive sleep apnea (OSA) on adult patients (>30 kg). iCodeConnect is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by displaying usage and therapeutic information that has been transmitted from the patient's Luna CPAP or Auto-CPAP therapy device located in the home to the clinician or healthcare professional. iCodeConnect also provides remote settings capabilities.

iCodeConnect is a web based patient management system used to store and manage sleep compliance and efficacy data uploaded from a Luna CPAP or Auto-CPAP device. iCodeConnect allows device patient data to be uploaded using a variety of methods, including manual entry, SD Card, and wireless transmission. Use of wireless transmission (i.e. WiFi) can provide wireless compliance monitoring and remote settings update functions. For wireless transmission, iCodeConnect consists of the wireless data transmission module Wi-Fi kit and web based iCodeConnect patient management software. The Wi-Fi Kit is intended to be used in conjunction with the Luna CPAP System (E-20C-H-O), Auto-CPAP System (E-20A-H-O / E-20AJ-H-O), which were cleared in K141770. 1) iCodeConnect Software is an analysis and management platform for the patient's therapy data. This platform, adopting the form of a website, not only realizes the uniform management of the patient's data and the information of the provider, the doctor and the patient, but also allows for the Wi-Fi Kit or other wireless communication module to transmit data and remotely updating therapy device settings, which reduces the inconvenience brought by the traditional mailing of SD card and makes data collection more timely. Wi-Fi Kit is an accessory module that attaches via USB cable to the data output port of a Luna® CPAP or Auto-CPAP devices. The wireless module Wi-Fi Kit uploads the device's therapy data to the iCodeConnect software with the help of Wi-Fi off-the-shelf technology. After connecting to the internet. the wireless kit shall automatically collect the user information, statistical information and detailed information in the therapy device for uploading.

The Luna® CPAP and Auto CPAP System are intended to deliver pressure for the treatment of Obstructive Sleep Apnea. The optional integrated hunidifier is indicated for the humidification and warming of air from the flow generator. These devices are intended for single patient use by prescription in the home or hospital/institutional environment on adult patients.

The materials of water chamber of Luna® CPAF and Auto CPAP device were changed. The suppliers of Polycarbonate and silicone were changed. The basic functional and performance characteristics of the Luna® CPAP and Auto CPAF devices are unchanged from the predicate devices (K141770).

The 3B Luna CPAP and Auto CPAP Systems are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. The optional integrated humidifier is indicated for the humidification and warming of air from the flow generator. These devices are intended for single patient use by prescription in the home or hospital / institutional environment on adult patients.

The Luna CPAP and Auto CPAP System is a microprocessor-controlled, blower-based system that generates positive airway pressure from 4 to 20 cm H20. The device is intended for use with a patient interface (mask). The device has been modified to include a color LCD, menu driven user interface, and a redesigned enclosure. The electrical circuit was redesigned to incorporate the color LCD. The basic functionality and performance characteristics of the Luna CPAP and Auto CPAP are unchanged from the predicate device RESmart CPAP and Auto CPAP (K132967).

The 3B and BMC RESmart® BPAP system is a Bi-level PAP (Bi-level Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA). The optional integrated humidifier is indicated for the humidification and warming of air from the flow generator device. These devices are intended for single-patient use by prescription in the home or hospital/intuitional environment on adult patients. It is to be used on patients (>66lbs/30kg) for whom positive airway pressure therapy has been prescribed. The system can deliver bi-level therapy or auto bi-level therapy.

The RESmart BPAP is a microprocessor controlled blower based bilevel positive pressure system that delivers two different positive pressure levels (IPAP/EPAP) from 4 to 25 cmH₂O. The dual pressure levels provide a more natural means of delivering pressure support therapy to the patient resulting in improved patient comfort. Two operation modes are being introduced, including the Auto Bi-Level mode and Spontaneous Bi-Level mode. Bi-Level therapy with automatically adjusting IPAP and EPAP levels is delivered in the Auto Bi-Level mode at the prescribed pressure range. The Spontaneous Bi-Level mode delivers fixed prescribed inspiratory and expiratory pressure. The BPAP device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask).

The iVolve® Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system. The iVolve "Mask is: to be used by adult patients (>66lb/30 kg) for whom positive airway pressure has been prescribed. intended for single-patient re-use in the home, hospital, and sub-acute environment.

The iVolve® N2 and Nasal Masks are respiratory nasal mask interfaces that directs airflow from a positive pressure device to the patient's nose. The iVolve® Full-Face Mask is a mask interface that directs air flow from a positive pressure device to the patient's nose or mouth. The iVolve® Mask Series is held in place with adjustable headgear that straps the mask to the face. The iVolve® is safe when used under the conditions and purposes intended as indicated the labeling provided with the product. The iVolve® is a prescription device supplied non-sterile.

The 3B and BMC RESmart CPAP and Auto-CPAP Systems are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. The optional integrated humidifier is indicated for the humidification and warming of air from the flow generator device. These devices are intended for single patient use by prescription in the home or hospital/institutional environment on adult patients.

The RESmart CPAP and Auto CPAP System is a microprocessor-controlled, blower-based system that generates positive airway pressure from 4 to 20 cm H2O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask). The RESmart CPAP and Auto CPAP device has been modified to include a smaller and quieter blower. The air circuit, embedded software, and controller board were upgraded to provide better performance. The basic functional and performance characteristic of the RESmart CPAP and Auto CPAP are unchanged from the predicate device RESmart CPAP and Auto CPAP (K110629).

The 3B and BMC RESmart CPAP and Auto CPAP Systems are intended to deliver positive pressure for the treatment of Obstructive Sleep Apnea. The optional integrated humidifier is indicated for the humidification and warming of air from the flow generator device. These devices are intended for single patient use by prescription in the home or hospital/institutional environment on adult patients.

The RESmart CPAP and Auto CPAP System is a microprocessorcontrolled, blower-based system that generates positive airway pressure from 4 to 20 cm H2O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask). The RESmart CPAP and Auto CPAP device has been modified to include porting the iCode software to a web-based application. The basic functional and performance characteristic of the RESmart CPAP and Auto CPAP is unchanged from the predicate device RESmart CPAP and Auto CPAP (K110629).