Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile

K-Number: K221014 · 2022-10-17

ApplicantEffortless Oxygen, LLC
Decision Date2022-10-17
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile is a medical device manufactured by Effortless Oxygen, LLC. It received FDA 510(k) clearance on 2022-10-17 under approval number K221014. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile?

Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile is a medical device that received FDA 510(k) clearance on 2022-10-17. It is manufactured by Effortless Oxygen, LLC. The 510(k) number is K221014.

When was Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile approved by the FDA?

Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile received FDA 510(k) clearance on 2022-10-17, under approval number K221014.

What company makes Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile?

Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile is manufactured by Effortless Oxygen, LLC.

What is the FDA product code for Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile?

The FDA product code for Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile is NFB.

Related Clinical Trials

NCT06385392 Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. COMPLETED NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT02703207 Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD RECRUITING NCT02389166 Optiflow in Sequential Non-Invasive Ventilation COMPLETED NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED NCT05984563 Optimization Strategy for Oxygen Delivery Under Cardiopulmonary Bypass TERMINATED

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40563006 Toward Transparent AI-Enabled Patient Selection in Cosmetic Surgery by Integrating Reasoning and Medical LLMs. Aesthetic plastic surgery (2025) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Related Devices (Code: NFB)

K151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter Labs K200401ApogeeIncoba Ltd D/B/A Dynaris K220591ProximaDynasthetics, LLC K250322Respond OC Conserving Regulator (130-0800)Responsive Respiratory

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.

↑