Search Results
Found 2 results
510(k) Data Aggregation
K Number
K231561Device Name
Pulmonary Function Tester, Model: A9
Manufacturer
Guangzhou Homesun Medical Technology Co., Ltd
Date Cleared
2024-02-21
(266 days)
Product Code
BTY
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Homesun Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pulmonary Function Tester (Model: A9) is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow-volume measurements shall be performed under the direction of a physician in the clinic, doctors' office or hospital. The Pulmonary Function Tester (Model: A9) is intended for use in patients from 4 years of age and older who can understand and perform instructions of the physician.
Device Description
The Pulmonary Function Tester (Model: A9) is a hand-held pulmonary function testing device which can be used by patients older than 4 years old under the direction of a physician in the clinic, doctors' office or hospital. The Pulmonary Function Tester (Model: A9) is comprised of the main unit (display screen, sensor and communication module), USB cable, application software (computer software, mobile software), and a power supply. The device use is very simple, it adopts mouth blowing method. The device uses a flow sensor to measure the air flow and volume of the patient's exhaled or inhaled air. According to the volume-time curve and the flow-volume curve, the pulmonary ventilation indicators of human respiratory physiology, such as slow vital capacity, maximum minute ventilation and forced vital capacity, are estimated and reported on the LCD screen and computer/mobile software. The pulmonary Function Tester is powered by lithium battery (DC 3.7V, 1500mAh) or tablet/computer USB port, or the equipped power supply.
Ask a Question
K Number
K191239Device Name
Smart Peak Flow Meter
Manufacturer
Guangzhou Homesun Medical Technology Co., Ltd
Date Cleared
2019-12-06
(212 days)
Product Code
BZH
Regulation Number
868.1860Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Homesun Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV 1) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma.
Device Description
Smart Peak Flow Meter (Model: B1) is a new type of hand-held pulmonary function testing device that measures peak expiratory flow (PEF) and forced expiratory Volume in 1 second (FEV1). Regular measurement is beneficial to the controlling of pulmonary disease such as asthma. The accuracy meets American Thoracic Society (ATS) Standard 2005 Revision.
The Smart Peak Flow Meter (Model: B1) is mainly composed of the main unit and removable mouthpiece. The use of B1 is very simple, user can master it quickly after reading the product user manual. It adopts mouth blowing method. After mouthpiece installation and powering on, keep breath steady, take a deep breath, hold the breath while put the mouthpiece into mouth, then exhale quickly and forcefully, taking as much time as possible. The results will be shown on the display screen and smart phone App. The mouthpiece should be removed regularly for cleaning.
The device can store 100 sets of data which can be transmitted to smart phone App through Bluetooth transmission mode for permanent storage. User can check the previous measurement records on the smart phone App.
Ask a Question
Page 1 of 1