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510(k) Data Aggregation
K Number
K200564Device Name
Aria System
Manufacturer
Date Cleared
2020-04-03
(30 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Inova Labs
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Aria sequential circulator is a programmable sequential, pneumatic compression device intended for use by medical professionals and patients at home, for the treatment of the following conditions:
- Chronic edema
- Lymphedema
- Venous insufficiency
- Wound healing
Device Description
The Aria system consists of two main components: A flow generator and a garment. The garment is to be wrapped around the limb, providing a comfortable fit. The garment has seven (7) chambers that are filled with air by the flow generator to provide compression on the extremity. The Aria system uses a compressand-release massage action, similar to the predicate, in order to stimulate lymphatic vessels in the treated area and encourage fluid clearance.
The Aria system retains similar hardware and performance features of the predicate device. Key features include flow generator, valves, A/C plug pack, lower limb garment, tubing, no-LCD User Interface and ON/OFF button. The Aria System contains a microprocessor-controlled flow generator/blower system that generates pressure from 0-45 mmHG to provide for effective treatment of the conditions described in the IFU.
The Aria flow generator has no control settings and delivers one pre-programmed therapy mode.
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K Number
K132205Device Name
ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM
Manufacturer
Date Cleared
2014-06-06
(325 days)
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
INOVA LABS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Actives DUO2 Oxygen Concentrator System is used on a prescriptive basis by adult patients who are diagnosed as requiring supplemental oxygen. The oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home or institutional/hospital setting.
Device Description
The Activox DUO2 Oxygen Concentrator is designed to be primarily a stationary device for home/institutional use. The LifeChoice Activox POC is a portable device that provides additional functionality of the Activox DUO2Oxygen Concentrator System. The Activox DUO2 Oxygen Concentrator base unit must be connected to the LifeChoice Activox POC a minimum of once every 45 days in order for the base unit to function as intent of this feature is to ensure the user at least periodically charges the battery powered LifeChoice Activox POC. While the Activox DUO2 is connected, it will charge the internal battery for the LifeChoice Activox POC. The Activox DUO2 can also charge the external battery (sold separately) for the LifeChoice Activox POC after the internal battery is charged.
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K Number
K113317Device Name
LIFECHOICE OXYGEN CONCENTRATOR
Manufacturer
Date Cleared
2011-12-28
(48 days)
Product Code
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
INOVA LABS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The LifeChoice Oxygen Concentrator is used on a prescriptive basis by patients who are diagnosed as requiring supplemental oxygen concentrator will provide supplemental, high concentration oxygen to these patients. It is not life supporting nor life sustaining. It may be used continuously in a home, institution or travel environment. The LifeChoice is also portable.
Device Description
The LifeChoice Oxygen Concentrator is a prescription use device for patients needing supplemental high concentration oxygen. The LifeChoice is not intended to be life supporting. The device provides approximately 90% oxygen to patients on a demand flow basis at an equivalent rate of 1.0 liter per minute to 5.0 liters per minute in increments of 1.0 liter per minute. The LifeChoice is a portable device which can be used in a home, institution or travel environment. The device uses molecular sieve pressure swing adsorption technology.
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