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510(k) Data Aggregation
K Number
K141967Device Name
PUREFILL OXYGEN COMPRESSOR
Manufacturer
INOVO, INC.
Date Cleared
2014-11-07
(109 days)
Product Code
CAW
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
INOVO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PureFill Oxygen Compressor is indicated to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended to be life supporting or life sustaining.
Environment of use: - Sub-acute care facilities and home settings
Device Description
The PureFill Oxygen Compressor is designed to accept low pressure (14-30 PSIG) oxygen from existing oxygen concentrators and pressurize the oxygen to 2,000 PSIG to fill patient's portable oxygen cylinders.
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K Number
K113111Device Name
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
Manufacturer
INOVO, INC.
Date Cleared
2011-12-08
(49 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
INOVO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chad Therapeutics Evolution Model OM-900M is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen up to 6 liters per minute, in their home and for ambulatory use.
Device Description
The Inovo Evolution OM-900M is a microprocessor-controlled device, which is a combination of a oxygen pressure regulator and a oxygen conserver, designed for use with ambulatory oxygen systems. The built in oxygen regulator reduces the oxygen pressure from the oxygen cylinder to ensure proper operation of the oxygen conserving device. The low pressure oxygen enters the conserver portion of the device where the breath detection circuitry and inhalation sensors control the low pressure oxygen to deliver a precise amount of supplemental oxygen at a specific point in the breathing cycle. It delivers boluses of oxygen that is equivalent to 1 to 6 liters per minute depending on the user setting. The OM-900M is also able to detect motion via a 3 axis accelerometer. If motion is detected the software will automatically increase the oxygen delivery(active mode) to the patient. After motion has ceased, the software will then revert to the original rest setting(rest mode). The motion technology is taken from a previously cleared device Chad Sage Model TD-100 - K033364.
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K Number
K103392Device Name
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER
Manufacturer
INOVO, INC.
Date Cleared
2010-12-17
(28 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
INOVO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chad Therapeutics Evolution Model OM-900 is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen up to 7 liters per minute, in their home and for ambulatory use
Device Description
The Inovo Evolution is a microprocessor-controlled device, which is a combination of a oxygen pressure regulator and a oxygen conserver, designed for use with ambulatory oxygen systems. The built in oxygen regulator reduces the oxygen pressure from the oxygen cylinder to ensure proper operation of the oxygen conserving device. The low pressure oxygen enters the conserver portion of the device where the breath detection circuitry and inhalation sensors convert the low pressure oxygen to deliver a precise amount of supplemental oxygen at a specific point in the breathing cycle. It delivers boluses of oxygen that is equivalent to 1 to 7 liters per minute depending on the flow rate setting
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K Number
K060751Device Name
INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR
Manufacturer
INOVO, INC.
Date Cleared
2006-07-18
(119 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
INOVO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Inovo AccuPulse Single Lumen Pneumatic Conserving Regulator is used to deliver a prescribed flow of medical-grade oxygen to the patient while conserving gas from a high-pressure oxygen cylinder, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.
Device Description
The Inovo, Inc. AccuPulse Conserving Regulator is a high pressure oxygen regulator and conserving device that is combined into a single compact unit. It is designed to extend the use time of oxygen cylinders. The AccuPulse senses the start of inhalation and immediately releases a short "pulse" of oxygen to the patient. Since all of the "pulse" of oxygen finds it way deep into the lungs, less oxygen is required to accomplish the same effect as traditional continuous-flow oxygen requlators.
The AccuPulse Conserving Regulator contains an integral regulator with a CGA 870 style yoke. The regulator portion reduced the pressure to about 22PSIG. The AccuPulse then delivers oxygen to the patient by sensing the beginning of inhalation using a diaphragm, which opens a sliding valve for a specific period of time controlled by pneumatic timing. The unit is designed to deliver 12 cc/lpm of oxygen to the patient at flows from 1 LPM to 6 LPM.
The AccuPulse also has a continuous mode that delivers selectable continuous flow in the event of device failure.
Patient inspiration is detected by a pressure-sensitive diaphragm set by the manufacturer in the range of 0.10 to 0.35 cm H2O. The device is capable of delivering a bolus of oxygen at the beginning of the patient's inhalation at breathing rates up to 40 breaths per minute (BPM). Patients with more rapid breathing rates than 40 BPM will cause the device to "skip" breaths.
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K Number
K051540Device Name
INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR
Manufacturer
INOVO, INC.
Date Cleared
2005-09-21
(103 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
INOVO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Inovo Independence Conserving Regulator is used to deliver a prescribed flow of medical-grade oxygen to the patient while conserving gas from a high-pressure oxygen cylinder, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.
Device Description
The Inovo, Inc. Independence Conserving Regulator is a high pressure oxygen regulator and conserving device that is combined into a single compact unit. It is designed to extend the use time of oxygen cylinders. The Independence senses the start of inhalation and immediately releases a short "pulse" of oxygen to the patient. Since all of the "pulse" of oxygen finds it way deep into the lungs, less oxygen is required to accomplish the same effect as traditional continuous-flow oxygen regulators. The Independence Conserving Regulator contains an integral regulator with a CGA 870 style yoke. The regulator portion reduced the pressure to about 22PSIG. The Independence then delivers oxygen to the patient by sensing the beginning of inhalation using a pressure switch, which opens a solenoid valve for a specific period of time controlled by a microprocessor. The unit is designed to deliver 16 cc/lpm of oxygen to the patient at flows from 1 LPM to 6 LPM. The unit is powered by a single "AA" battery. The Independence also has a continuous flow back-up mode that delivers selectable continuous flow in the event of battery or device failure. The device has a two-color LED to indicate battery status. By depressing a "Battery test" switch, the device will show a Green light to indicate the battery is good. When the battery is below 0.9 vDC, the LED will be Red, indicating the battery must be changed. Under any circumstance, the "Continuous" mode can supply oxygen therapy in the event of battery failure. Patient inspiration is detected by a pressure switch set by the manufacturer in the range of 0.10 to 0.35 cm H2O. The device is capable of delivering a in the fango on at the beginning of the patient's inhalation at breathing rates up to 40 breaths per minute (BPM). Patients with more rapid breathing rates than 40 BPM will cause the device to "skip" breaths.
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K Number
K031983Device Name
INOVO, INC, ECONOMIZER CONSERVING REGULATOR
Manufacturer
INOVO, INC.
Date Cleared
2003-09-15
(81 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
INOVO, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Economizer Conserving Requlator is used to deliver a prescribed flow of gas to the patient while conserving gas, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.
Device Description
The Inovo, Inc., Economizer Conserving Regulator is a high pressure oxygen requlator and conserving device that is combined into a single compact unit. It operates in the same manner as traditional oxygen pressure regulators with the added benefit of having a conserving device included. It is constructed with an aluminum one piece body with all brass in the high pressure zones. The system is designed for an ambulatory patient with a high pressure oxygen cylinder. This unit requires no electrical power source. It operates with an operating pressure of 200 to 3000 psig and a nominal outlet pressure of 22 psi.
The device can function as a standard continuous flow regulator or as a conserving device which will double a patient's ambulatory time over that of a continuous oxygen system.
In conserving mode, the flow of oxygen is controlled by the patients inhalation and exhalation, which triggers a sensing diaphragm within the control module. As a result, the unit starts flowing oxygen when the user begins the inhalation cycle. Conversely, the unit shuts off the flow of oxygen when the user ceases inhalation.
It includes a click style flow control with selectable outlet flow that ranges 1 to 6 LPM by .5 LPM increments. The device can easily be switched between continuous or conserve mode without turning the device off.
The device uses a dual lumen cannula attached to two outlet ports. The first port senses the inhalation of the patient . The second port delivers the oxygen. In the "Conserve" mode, the device should be used only with the Hudson Dual Lumen Cannula (K# 961150) or a cannula with the same pneumatic characteristics.
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