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510(k) Data Aggregation
K Number
K202062Device Name
wheezo WheezeRate Detector
Manufacturer
Respiri Limited
Date Cleared
2021-03-11
(227 days)
Product Code
PHZ
Regulation Number
868.1900Why did this record match?
Applicant Name (Manufacturer) :
Respiri Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
wheezo is intended to detect and record abnormal breath sounds (continuous adventitious breath sounds/CABS) at the windpipe (trachea), reported as WheezeRate in adults and children (2 years and older). A licensed health care professional's advice is required to understand the meaning and importance of the wheezo readings.
Device Description
The Respiri wheezo WheezeRate Detector contains the following components (1) wheezo Sensing Device (2) wheezo App and (3) Secure cloud server. The wheezo transfers a user's breath sound data to the App using a Smart Device. The sound data is analysed in the alqorithm, which is integrated inside the App and runs on the Smart Device.
It is a hand-held, battery-operated, computer-based, pulmonary sound detector that utilises microphones to acquire, amplify, filter, record and quantify the presence of wheezing. The breath sound is transferred using Bluetooth® technology to smartphone for detection and quantification of wheeze presence, expressed as wheeze rate.
The wheezo samples breathing and ambient sounds, and streams the audio data wirelessly via Bluetooth SPP profile to a connected Smart Device Mobile App. It does not store any recorded data into persistent memory. The Mobile App, through user interaction, must perform the standard Bluetooth pairing process to the wheezo prior to use. Wheeze rate is calculated by the Mobile App using the audio data received from the sensing device. A remote device can connect to the wheezo Sensing Device via Standard Bluetooth. The device supports Bluetooth Serial Port Protocol (SPP) mode, where asynchronous serial packets are transported using Bluetooth RFCOMM protocol. When not paired, the sensing device will be in discoverable mode.
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