Air Smart Extra Spirometer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222443 FDA 510(k)
- FDA Product Code
- BZG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1840 FDA 510(k)
- Regulation Number
- 868.1840 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AirSmart Extra Spirometer is a diagnostic device classified as a spirometer, designed to measure lung function by assessing airflow and lung volumes. It evaluates parameters such as forced expiratory volume (FEV₁), forced vital capacity (FVC), and peak expiratory flow (PEF) to aid in the assessment of respiratory conditions.
This device is intended for use in clinical and home settings, supplied as a single-use or reusable unit depending on the configuration. It operates under regulatory authorisations including FDA 510K clearance, MDD, and MDR compliance, with a classification as a Class II medical device. Storage and usage adhere to manufacturer guidelines, ensuring accurate and reliable spirometry results for diagnostic purposes.
Frequently asked questions
Can the AirSmart Extra Spirometer be used in both clinical and home settings, and if so, how does its design accommodate both environments?
Yes, the AirSmart Extra Spirometer is explicitly designed for use in both clinical and home settings. Its versatility allows it to function effectively in either environment, providing accurate measurements of lung function parameters like FEV₁, FVC, and PEF. The device is available in configurations that support either single-use or reusable units, ensuring flexibility for different usage scenarios while maintaining reliability and ease of use.
What types of regulatory approvals does the AirSmart Extra Spirometer hold, and how does this impact its availability?
The AirSmart Extra Spirometer holds regulatory approvals including FDA 510K clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) compliance. These approvals confirm that the device meets stringent safety, performance, and quality standards required for commercial distribution in the respective markets. This regulatory pathway ensures its availability for clinical and home use under the oversight of relevant health authorities.
Is the AirSmart Extra Spirometer available in multiple configurations, and if so, how do I determine whether to choose a single-use or reusable model?
The AirSmart Extra Spirometer is supplied in configurations that support both single-use and reusable units, depending on the specific model or setting requirements. The choice between single-use and reusable depends on factors like infection control protocols, frequency of use, and cost considerations. Single-use models are ideal for clinical settings where hygiene is critical, while reusable models may be more practical for high-volume or long-term home use, provided proper cleaning and maintenance protocols are followed.
What key lung function parameters does the AirSmart Extra Spirometer measure, and how are these used in respiratory assessments?
The AirSmart Extra Spirometer measures critical lung function parameters such as forced expiratory volume (FEV₁), forced vital capacity (FVC), and peak expiratory flow (PEF). These metrics are essential for assessing respiratory conditions, such as asthma or chronic obstructive pulmonary disease (COPD), by evaluating airflow obstruction, lung volume, and overall lung function. The device provides objective data to aid clinicians in diagnosing, monitoring, and managing respiratory health.
Are there specific storage guidelines for the AirSmart Extra Spirometer, and how should I ensure its accuracy and reliability over time?
While the exact storage guidelines are provided by the manufacturer, the AirSmart Extra Spirometer—like all medical devices—requires adherence to recommended conditions to maintain accuracy and reliability. This typically includes protecting the device from extreme temperatures, humidity, and physical damage, as well as following any calibration or maintenance protocols outlined in the user manual. Proper storage ensures consistent performance and extends the device’s operational lifespan, particularly for reusable models.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K222443 | Class II | Active |
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Manufacturer
- Manufacturer
- Feellife Health Inc.
- FDA Applicant
- Feellife Health, Inc.
Sources (2)
- FDA 510(k) K222443 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026