HealthLife Oxygen Concentrator Model AS009
FDA 510(k)Class II (US FDA 510(k))
by Airsep Corp.
Identifiers
- 510(k) Number
- K012037 FDA 510(k)
- FDA Product Code
- CAW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5440 FDA 510(k)
- Regulation Number
- 868.5440 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HealthLife Oxygen Concentrator Model AS009 is a portable oxygen generator designed to concentrate oxygen from ambient air for inhalation therapy. It delivers supplemental oxygen at a nominal flow rate of 9 liters per minute, with an output concentration of approximately 38%. This device is classified as a Class II medical device under the FDA’s special controls for home-use oxygen therapy and respiratory devices, specifically under product code CAW.
The device is intended for use in both clinical and home settings, operating by drawing ambient air and processing it to produce concentrated oxygen. Supplied as a reusable medical device, it requires no sterilization and is regulated under FDA 510(k) clearance (K012037). The device adheres to regulatory standards for portable oxygen generators, with no specific MRI safety or single-use requirements noted. Storage and maintenance instructions are manufacturer-specific but typically involve proper ventilation and adherence to operational guidelines.
Frequently asked questions
What is the HealthLife AS009 oxygen concentrator used for?
The HealthLife AS009 is designed to concentrate oxygen from ambient air for inhalation therapy. It provides supplemental oxygen at a nominal flow rate of 9 liters per minute with an output concentration of approximately 38%, making it suitable for both clinical and home-use settings where patients require continuous oxygen support.
Is the HealthLife AS009 a single-use or reusable device?
The HealthLife AS009 is a reusable medical device. It does not require sterilization between uses, but it must be maintained according to the manufacturer’s guidelines to ensure proper function and safety.
What are the key specifications for oxygen output and flow rate?
The device delivers oxygen at a nominal flow rate of 9 liters per minute with an output concentration of about 38%. These specifications are designed to meet the needs of patients requiring supplemental oxygen therapy in portable or stationary settings.
Does the HealthLife AS009 require any special storage conditions?
The manufacturer recommends proper ventilation and adherence to operational guidelines for storage and maintenance. While no specific sterility requirements exist due to its reusable nature, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve functionality.
What regulatory approval does the HealthLife AS009 hold?
The HealthLife AS009 is FDA-cleared under 510(k) (K012037) and classified as a Class II medical device under product code CAW for home-use oxygen therapy and respiratory devices. It adheres to regulatory standards for portable oxygen generators.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K012037 FDA 510(k) - HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009, HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 (K012037) — FDA 510 (k ..., PDF K012037 - Healthlife Oxygen Concentrator Model As009, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K012037 | Class II | Active |
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Manufacturer
- Manufacturer
- Airsep Corp.
Sources (1)
- FDA 510(k) K012037 24 fields · synced Oct 1, 2026