Safey Peak Flow Meter
The Safey Peak Flow Meter measures peak expiratory flow and the volume exhaled in the first second of a forced breath. It is a pocket-sized home device for tracking respiratory function in…
The Safey Peak Flow Meter measures peak expiratory flow and the volume exhaled in the first second of a forced breath. It is a pocket-sized home device for tracking respiratory function in adults, adolescents and children older than five.
Airflow rotates a turbine vane, and infrared sensors detect its direction and speed. The device calculates PEF and FEV1 and sends the results by Bluetooth Low Energy to the Safey smartphone app.
Listed Item
Safey Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment. The device is designed for children greater than five years of age, adolescent and adult subjects.
Power and Records
Two AAA alkaline batteries power the meter. The app displays and stores test results for later review and also provides medication reminders. The reusable mouthpiece forms the patient interface for the breathing test.
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 | Safey Medical Devices Pvt, Ltd., India |
|---|---|
| FDA product code | BZH |
| Device type | Meter, Peak Flow, Spirometry |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1860 |
| 510(k) | K200832 |
| Record published | 2022-02-04 |
| Record revised | 2025-01-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 75 to 100 KiloPascal; Handling environment humidity 10 to 90 % RH; Handling environment temperature -10 to 70 °C |
| Sizes | Weight 300 g |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 165253 | Weight 300 g | 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 |
|---|---|
| K200832 | 2020-07-30 |
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.