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FDA 510(k)

Portable oxygen concentrator (JLO-190P)

K-Number: K252616 · 2025-12-22

ApplicantShenzhen Homed Medical Device Co., Ltd.
Decision Date2025-12-22
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Portable oxygen concentrator (JLO-190P) is a medical device manufactured by Shenzhen Homed Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2025-12-22 under approval number K252616. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portable oxygen concentrator (JLO-190P)?

Portable oxygen concentrator (JLO-190P) is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by Shenzhen Homed Medical Device Co., Ltd.. The 510(k) number is K252616.

When was Portable oxygen concentrator (JLO-190P) approved by the FDA?

Portable oxygen concentrator (JLO-190P) received FDA 510(k) clearance on 2025-12-22, under approval number K252616.

What company makes Portable oxygen concentrator (JLO-190P)?

Portable oxygen concentrator (JLO-190P) is manufactured by Shenzhen Homed Medical Device Co., Ltd..

What is the FDA product code for Portable oxygen concentrator (JLO-190P)?

The FDA product code for Portable oxygen concentrator (JLO-190P) is CAW.

Related Clinical Trials

NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT07512687 Titrated Ambulatory Oxygen in Fibrotic ILD and COPD With Isolated Exertional Hypoxemia NOT_YET_RECRUITING

Related PubMed Literature

PMID: 34857221 Comparative study of a novel portable indirect calorimeter to a reference breath-by-breath instrument and its use in telemedicine settings. Clinical nutrition ESPEN (2021)

Other Devices by Shenzhen Homed Medical Device Co., Ltd.

K161586The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) K170886HOMED Mesh Nebulizer K212395Nebulizer

Related Devices (Code: CAW)

K160630Invacare Platinum Mobile Oxygen ConcentratorInvacare Corporation K162433GCE Zen-O Portable Oxygen ConcentratorOxus, Inc. K182454O2 Concepts Oxlife Independence Model 301-0001O2 Concepts, LLC K172234Oxygen ConcentratorSysmed (China) Co., Ltd. K172648Drive DeVilbiss iGo 2 Portable Oxygen ConcentratorDevilbiss Healthcare, LLC K191159Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with ConnectivityInvacare Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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