Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
Taiwan Aulisa Medical Devices Technologies, Inc.The Aulisa Infant Oximeter Module (2nd Gen.) is a wireless, foot-worn sensor device designed to continuously measure oxygen saturation (SpO2) and pulse rate in infants. It sends the measured data via Bluetooth to a mobile device running a dedicated app for display and monitoring. This helps caregivers monitor infant vital signs in hospitals, home care, and medical facilities non-invasively in real time, with visual and auditory alarms for abnormalities.
Intended Use
The Aulisa Infant Oximeter Module (2nd Gen.) is indicated for spot-checking and/or continuous monitoring SpO2 and pulse rate of infant patients during non-motion and under well-perfused conditions in hospitals, medical facilities, home care, and subacute environments. The parameters derived by the device are transmitted to a commercially available mobile device that runs an Aulisa-developed application for display and review.
Technology
The device is a wireless, foot-worn sensor module that uses non-invasive red and infrared technology to measure SpO2 and pulse rate. Data is transmitted via Bluetooth to third-party mobile devices running an Aulisa-developed app. It includes an oximeter box and a reusable transmissive sensor, with audible and visual alarms generated through the app when abnormal data or technical errors are detected.
Performance
The device successfully passed electrical safety, environmental stress, electromagnetic immunity, performance, mechanical durability, biocompatibility, software validation, security testing, wireless coexistence, clinical testing, usability, bench performance, durability, and battery life testing. Clinical testing validated SpO2 measurement accuracy on healthy subjects with different skin tones according to ISO 80601-2-61 requirements with ARMS less than 3 digits over 70-100% saturation range, confirming safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/15/2023
1 year, 1 months - 2
FDA Approval
1/30/2025
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