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510(k) Data Aggregation
K Number
K121260Device Name
TROOPER OXYGEN CONCENTRATOR
Manufacturer
Date Cleared
2012-09-21
(148 days)
Regulation Number
868.5440Why did this record match?
Applicant Name (Manufacturer) :
VBOX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VBOX Trooper oxygen concentrator device is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The VBOX Trooper may be used in home, institution, vehicle and various mobile environments.
Device Description
The Trooper oxygen concentrator utilizes a molecular sieve and differential pressure swing adsorption to separate the gases in ambient air. The device takes the room air and concentrates the oxygen portion to produce a pulse of oxygen between 87-94 % in purity. When the patient inhales, the device senses the pressure change and is triggered to release the oxygen pulse. In between breaths, the device regenerates an oxygen pulse and waits for the next inhalation breath before dispensing it.
The front panel of the Trooper contains controls and indicators such as, device status indicator LEDs, an ON/OFF button, oxygen flow rate controls, and flow rate and battery status displays. The oxygen outlet is also located on the front panel of the device.
The VBOX Trooper oxygen concentrator system will be provided under a single model number, A-1000, which includes the following items:
- One (1) Trooper Oxygen Concentrator Unit
- Two (2) Li-Ion Batteries (only one connected to the device at a time)
- One (1) Auxiliary AC Power Supply
- One (1) Battery Charger
- One (1) Carrying case
- One (1) nasal cannula
- User manual
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