GoSpiro

GoSpiro is described as a single-patient spirometer for basic lung-function and spirometry testing. The filing names adults and children over five and physician offices, clinics, and home…

Registry build 21.09.26

GoSpiro is described as a single-patient spirometer for basic lung-function and spirometry testing. The filing names adults and children over five and physician offices, clinics, and home settings.

The spirometer sends real-time lung-function data over Bluetooth to a computer, tablet, or smartphone. It performs full flow-volume loops with inspiratory and expiratory data.

Listed Item

Device Description: The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinics and home settings to conduct basic lung function and spirometry testing. It is a single-patient, use device. The GoSpiro spirometer transmits real-time lung function data to computers, tablets or smartphones over a Bluetooth connection for tele-healthcare applications. The GoSpiro performs full flow-volume loops including inspiratory and expiratory data. The internal program performs all of the calculations for measurements to meet American Thoracic Society and European Respiratory Society requirements. It has built-in quality control measurements and transmits indices of measurement quality including time to peak flow, back-extrapolated volume, total expiratory time, and end-expiratory flow detection. It is used with the GoSpiro App display and communications software on a smartphone or tablet. The GoSpiro is powered by an internal rechargeable Lithium battery and is charged via its USB charging station connected to a USB power source. The device complies with ES 60601-1, IEC 60601-1-2, and IEC 60601-1-11. The fundamental technology to measure flow is a vertical turbine volume sensor. The turbine transducer measures expired air directly at B.T.P.S. (body temperature and pressure with saturated water vapor) thus avoiding the requirement for temperature correction on exhalation. An electronic temperature sensor on the device PCB measures atmospheric temperature, thus enabling correction of inspired volumes and flows. This transducer is insensitive to the effects of condensation and temperature and avoids the need for individual calibration prior to performing a test. Indications for Use: The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinics and home settings to conduct basic lung function and spirometry testing. It is a single-patient use device.

Data Transfer

The GoSpiro App provides display and communications software on a smartphone or tablet.

10manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (5), Guangdong (3), Fujian (1). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BZG
Manufacturer City Province Registered as Device types
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Dong Guan Guangdong Contract manufacturer 29
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Intersurgical Medical Apparatus (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 12
Ningbo Tianyi Medical Appliance Co., Ltd. Ningbo Zhejiang Contract manufacturer 11
GVS Technology (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
Flexible Circuit Technologies Shenzhen Shenzhen Guangdong Contract manufacturer 1
Changshu Rozer Sterilization Technology Co., Ltd. Changshu Jiangsu Contract manufacturer 43
Rozer Sterilization Technology Shuyang Company Limited Shuyang Jiangsu Contract manufacturer 33
Feellife Health Inc. Shenzhen Guangdong Contract manufacturer 8

Record

Regulatory record for GoSpiro
Listed by Monitored Therapeutics, Inc., United States
FDA product code BZG
Device type Spirometer, Diagnostic
Device class Class 2
Regulation 21 CFR 868.1840
Establishment Specification developer, Complaint-file establishment, Manufacturer
510(k) K163249
Record published 2019-02-02
Record revised 2026-04-29 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries serial number
Storage Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 30 to 75 % RH; Handling environment temperature 17 to 35 °C; Handling environment temperature 63 to 95 °F; Storage environment atmospheric pressure 0 to 5 KiloPascal; Storage environment humidity 15 to 95 % RH

Catalogue Numbers

Catalogue numbers for GoSpiro
Catalogue number Size Status
45-90058 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Polytech Filter Polytechnic Resources, Inc. 190
Model 4000 Vitalograph Ireland Ltd. 115
Astra Spirometer S D I Diagnostics Inc 90
MIR Mir Medical International Research 56
Curaplex TRI-Anim Health Services, Inc. 55
Alpha Vitalograph Ireland Ltd. 48
Welch Allyn, Inc. Welch Allyn, Inc. 47
MGC Diagnostics Medical Graphics Corp. 42
Astraguard S D I Diagnostics Inc 39
PFT Vitalograph Ireland Ltd. 38
Vyaire Jaeger Medical GmbH 36
BVF Vitalograph Ireland Ltd. 29

Showing 12 of 123. All products under Spirometer, Diagnostic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K202837 2020-12-04
K163249 2017-03-24

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