Adult Peakflow Meter

The Besmed adult peak flow meter measures the highest airflow produced during a forced exhalation. It helps users track changes in breathing over time. The listed PF-29100 is the full-range…

Registry build 21.09.26

The Besmed adult peak flow meter measures the highest airflow produced during a forced exhalation. It helps users track changes in breathing over time. The listed PF-29100 is the full-range adult model, with a measuring range of 50 to 800 liters per minute.

Exhaled air moves a spring-loaded piston and pointer along a calibrated scale. A mouthpiece with a one-way valve prevents inhalation through the measuring section. The handheld mechanical meter does not require an electronic display to show the result.

Repeated Use

The meter is intended for repeated use by one patient and is available over the counter. Its mouthpiece and one-way valve are cleaned between uses with mild detergent and warm tap water, following the device instructions.

6manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

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.

Chinese manufacturers registered for FDA product code BZH
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

Regulatory record for Adult Peakflow Meter
Listed by Besmed Health Business Corporation, Taiwan
FDA product code BZH
Device type Meter, Peak Flow, Spirometry
Device class Class 2
Regulation 21 CFR 868.1860
Establishment Manufacturer, Exporter
510(k) K172804
Record published 2018-01-16
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Adult Peakflow Meter
Catalogue number Size Status
PF-29100 In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
Clearance Decision date
K172804 2018-01-11

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer