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510(k) Data Aggregation
K Number
K221014Device Name
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
Manufacturer
Effortless Oxygen. LLC
Date Cleared
2022-10-17
(195 days)
Product Code
NFB
Regulation Number
868.5905Why did this record match?
Applicant Name (Manufacturer) :
Effortless Oxygen. LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Effortless Oxygen Conserver Systems are intended to deliver medical-grade oxygen for patients that require supplemental oxygen from oxygen gas sources. Pulsing oxygen allows patients to ambulate longer than they would with a continuous flow regulator on the same cylinder. The Effortless MOBILE may be used in hospital, healthcare facilities, or home care environments. The Effortless PRO is only intended for hospital and healthcare facilities under professional use.
Device Description
The Effortless Oxygen Conserver Systems (EOCS) is a microprocessor-controlled device, which contains an oxygen pressure regulator and oxygen conserver. Depending upon the model they have been designed for use in ambulatory, home and medical facility settings to supply medical-grade oxygen therapy to patients. The built in oxygen regulator reduces oxygen pressures from an oxygen cylinder or from hospital wall supplies. There are two configurations: The Effortless Pro which connects to hospital wall oxygen and the Effortless Mobile which connects to tanks.
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