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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.
MONITORED THERAPEUTICS, INC.
45-90058
In Commercial Distribution
- 00860000692809 ()
45-90058
- Diagnostic spirometer, professional
Light weight (~2.5 Kg.) and portable therapeutic medical laser device (measuring ~258.65mm x 238.43m x 88.86mm) disc shaped, indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. The noninvasive laser treatments (Continuous Wave - CW power 28W and Intense Super Pulse - ISP power 30W) are in the form of non-ionizing radiation in which the invisible light wave doses (810nm +/- 10nm, 915nm +/- 10nm, 980nm +/- 10nm) and visible light wave aiming beam (650nm +/- 20nm) are not cumulative and do not create changes in cellular DNA. The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair. The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste. The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
SUMMUS MEDICAL LASER, LLC
P4H
In Commercial Distribution
- B679SLP4H0 ()
SLP4H
- Musculoskeletal/physical therapy laser, professional