Inogen Rove 4 Portable Oxygen Concentrator
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Inogen, Inc.
Identity
- Trade Name
- Inogen Rove 4 Portable Oxygen Concentrator EUDAMEDInogen Rove 4 FDA UDI
- Generic Name
- Mobile/portable oxygen concentrator FDA UDI
- Device Name
- Inogen Portable Oxygen Concentrators EUDAMEDThe Inogen Rove 4™ Portable Oxygen Concentrator system 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 Inogen Rove 4™ Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments. FDA UDI
- Model / Reference
- IS-401 EUDAMED10-10417-00-01 (BT) FDA UDI
- Description
- The Inogen Rove 4™ Portable Oxygen Concentrator system 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 Inogen Rove 4™ Oxygen Concentrator may be used in a home, institution, vehicles and various mobile environments. FDA UDI
Identifiers
- Catalog Number
- IO-401 FDA UDI
- Primary DI / UDI-DI
- 00817131020414 EUDAMEDFDA UDI
- Basic UDI-DI
- 081713102POCBU EUDAMED
- Direct Marketing DI
- 00817131020414 EUDAMED
- 510(k) Number
- K222086 FDA 510(k)
- FDA Product Code
- CAW FDA 510(k)FDA UDI
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
- GMDN Term
- Mobile/portable oxygen concentrator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 868.5440 FDA 510(k)
- Regulation Number
- 868.5440 FDA 510(k)FDA UDI
- Market of Registration
- Iceland EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Inogen Rove 4 Portable Oxygen Concentrator is a Generator, Oxygen, Portable device designed to deliver concentrated oxygen therapy to patients. It operates via pulse-dose technology, providing adjustable flow settings to meet varying clinical needs. The device is intended for use in outpatient and home settings, offering mobility for patients requiring supplemental oxygen.
The Inogen Rove 4 is supplied as a reusable, non-sterile medical device, weighing approximately 2.8–2.9 lbs depending on battery configuration. It features four pulse-dose settings (1–4) with a maximum output of 840 mL/min and includes interchangeable battery options for extended use. Regulated under FDA 510(k) clearance (K222086) and MDR, the device adheres to 21 CFR 868.5440 for portable oxygen generators. No MRI safety classification is specified.
Frequently asked questions
Is the Inogen Rove 4 Portable Oxygen Concentrator designed for single-use or can it be reused?
The Inogen Rove 4 is a reusable medical device, not intended for single-use. It is supplied as a non-sterile device, meaning it is meant to be cleaned and reused by the same patient or between patients under proper hygiene protocols. Reusability is a key feature for portability and cost-effectiveness in outpatient and home settings.
What are the weight and battery options for the Inogen Rove 4, and how does this affect its portability?
The Inogen Rove 4 weighs approximately 2.8–2.9 lbs, depending on the battery configuration. This lightweight design enhances portability, allowing patients to carry it easily while maintaining extended use through interchangeable battery options. The device is specifically designed for mobility, making it suitable for outpatient and home use.
How does the pulse-dose technology in the Inogen Rove 4 differ from traditional continuous-flow oxygen delivery?
The Inogen Rove 4 uses pulse-dose technology, which delivers oxygen in timed bursts synchronized with the patient’s breathing cycle rather than a continuous flow. This approach conserves oxygen output while providing adjustable settings (1–4) to meet varying clinical needs, making it more efficient for portable use compared to traditional continuous-flow devices.
What are the maximum oxygen output and flow settings available on the Inogen Rove 4, and how might this impact patient selection?
The device offers a maximum output of 840 mL/min across four pulse-dose settings (1–4). These adjustable settings allow clinicians to tailor oxygen delivery to individual patient requirements, ensuring flexibility for mild to moderate oxygen dependency in outpatient or home settings. Higher flow needs may require alternative devices.
How should the Inogen Rove 4 be stored, and are there any special considerations for its maintenance?
The Inogen Rove 4 is a reusable, non-sterile device, so storage should follow manufacturer guidelines to prevent contamination. It should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Regular maintenance, including cleaning and battery care, is essential for optimal performance and longevity, as outlined in the device’s user manual.
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: Inogen Rove 4: 2.8 lb Lightweight Portable Oxygen Concentrator, Inogen Rove 4 Portable Oxygen Concentrator — 4 Settings, 2.9 lb, Rove 4 Freedom Package 3 - Inogen, PDF ROVE 4 - cdn.inogen.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K222086 | Class II | Active |
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Manufacturer
- Manufacturer
- Inogen, Inc.
- FDA Applicant
- Inogen
Sources (3)
- FDA 510(k) K222086 24 fields · synced Sep 20, 2026
- FDA UDI 7eb7263e-4300-47b7-a880-1dddc53a1349 36 fields · synced May 30, 2026
- EUDAMED 75983b0f-cc13-4efe-bd7c-0c4150c5710e 61 fields · synced Aug 1, 2026