Device Type: Anesthesiology - Therapeutic
FDA Description:
A nebulizer is a Class II medical device which transforms liquid medication into a fine aerosol for inhalation, delivering treatment directly to the lungs. Nebulizers must meet FDA safety and performance standards, including compliance with biocompatibility and effectiveness requirements. The FDA product code for nebulizer is CAF.
A nebulizer is a medical device designed to deliver medication directly to the lungs in the form of a fine mist, providing effective treatment for respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), and other pulmonary disorders. By transforming liquid medication into an aerosol, the nebulizer ensures efficient delivery to the respiratory tract, offering targeted therapy for symptom relief and condition management.
Nebulizers are often used in both clinical and home settings. They are available in portable and stationary models, with features tailored to meet diverse patient needs. Portable nebulizers, powered by batteries or USB, enhance mobility and convenience, making them ideal for on-the-go therapy. Stationary models, typically powered by electricity, are well-suited for extended or intensive treatment sessions.
The device typically consists of a compressor or ultrasonic unit, a medication cup, and a mouthpiece or mask. The compressor generates airflow to atomize the medication, while the mouthpiece or mask allows the patient to inhale the therapeutic mist. Advanced nebulizers incorporate features like adjustable mist flow, noise reduction, and compact designs for ease of use and storage.
Engineered for safety and efficiency, nebulizers undergo rigorous testing to meet regulatory standards, ensuring they provide reliable and effective respiratory care for diverse patient populations.