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Sign in to claim this brandMedical Acoustics
US
Last updated May 23, 2026
What Medical Acoustics makes
Medical Acoustics manufactures positive pressure airway secretion-clearing devices designed to assist in clearing mucus from the lungs. These include the Lung Flute® Therapeutic, Lung Flute® for Home Care, and Lung Flute® for Hospitals & Clinics, each tailored for different clinical settings.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI databases. The portfolio is regulated in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Medical Acoustics manufacture?
Medical Acoustics specializes in positive pressure airway secretion-clearing devices. These devices are designed to help clear mucus from the lungs, improving respiratory function. The company’s portfolio includes products like the Lung Flute® Therapeutic, Lung Flute® for Home Care, and Lung Flute® for Hospitals & Clinics, each developed for specific clinical environments.
Where is Medical Acoustics based, and where are its devices regulated?
Medical Acoustics is based in the United States. Its devices are regulated under U.S. FDA guidelines, specifically as Class II medical devices, which indicates a moderate level of risk requiring special controls to ensure safety and effectiveness.
Which regulatory registries list Medical Acoustics’ devices?
Medical Acoustics’ devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries track devices that have undergone the required regulatory pathways to demonstrate compliance with U.S. safety and performance standards.
How are Medical Acoustics’ devices classified under FDA regulations?
Medical Acoustics’ devices are classified as Class II under FDA regulations. This classification means they pose a moderate risk and require special controls beyond general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lung Flute® Therapeutic | 1005-01 | FDA UDI | Class II | Active |
| Lung Flute® for Home Care | 1003-01 | FDA UDI | Class II | Active |
| Lung Flute® for Hospitals & Clinics | 1004-01 | FDA UDI | Class II | Active |
| Lung Flute | K060439 | FDA 510(k) | Class II | Active |
| Lung Flute Therapeutic | K091557 | FDA 510(k) | Class II | Active |
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