Aluna
Aluna is described in the FDA filing as a small hand-held peak flow meter. The stated monitoring measures are FEV1 and PEF, for home use, with possible clinician use for in-office…
Aluna is described in the FDA filing as a small hand-held peak flow meter.
The stated monitoring measures are FEV1 and PEF, for home use, with possible clinician use for in-office monitoring.
Listed Item
Aluna Spirometer
Stated Use and Limits
The filing states that Aluna is designed for children age five or older, adolescents, and adults, and is not recommended for children under five. It describes the device as capturing lung health information and making it available through a mobile application. The excerpt supports monitoring FEV1 and PEF; it does not establish additional diagnostic uses.
Who Else Makes It
Concentrated in Guangdong (4), Chongqing (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Shenzhen BI-Rich Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Chongqing Sonmol Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 9 |
| Onbo Electronic (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Guangzhou Homesun Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 4 |
| Taian Dalu Medical Instrument Co., Ltd. | Taian | Shandong | Contract manufacturer | 2 |
Record
| Listed by | Knox Medical Diagnostics, Inc., United States |
|---|---|
| FDA product code | BZH |
| Device type | Meter, Peak Flow, Spirometry |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1860 |
| 510(k) | K193311 |
| Record published | 2020-09-10 |
| Record revised | 2021-03-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 75 % RH; Storage environment temperature -20 to 45 °C; Handling environment humidity 10 to 95 % RH; Handling environment temperature -20 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 000050-FGI | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mini Wright | Clement Clarke Intl., Ltd. | 12 |
| Personal Best | Respironics Respiratory Drug Delivery (Uk), Ltd. | 10 |
| In-Check | Clement Clarke Intl., Ltd. | 8 |
| PFM | Vitalograph Ireland Ltd. | 7 |
| SpiroFlow | Spirometrics, Inc. | 4 |
| Meter, Peak Flow, Spirometry | Salter Labs | 3 |
| Airzone | Clement Clarke Intl., Ltd. | 3 |
| AincA® | Anesthesia Associates, Inc. | 3 |
| Meter, Peak Flow, Spirometry | Galemed Corp. | 3 |
| Curaplex | TRI-Anim Health Services, Inc. | 3 |
| Asthma Check | Respironics Respiratory Drug Delivery (Uk), Ltd. | 3 |
| Vyaire | Jaeger Medical GmbH | 2 |
Showing 12 of 53. All products under Meter, Peak Flow, Spirometry
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232588 | 2024-11-25 |
| K193311 | 2020-03-25 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.