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510(k) Data Aggregation
(167 days)
YUWELL® Finger Pulse Oximeters are non-invasive, non-sterile, reusable, and spot-checking devices that measure and display SpO₂ and pulse rate (PR) via the patient's finger. They are indicated for use in adults and children (weight > 30 kg) and are intended for professional and home settings. These devices are unsuitable for continuous monitoring, use during motion, or in patients with low perfusion.
YUWELL® Finger Pulse Oximeter (the Oximeter) is a finger pulse oximeter designed to measure functional oxygen saturation (SpO₂) of arterial hemoglobin and pulse rate (PR) in adults and children (weight > 30 kg). The device operates by detecting changes in light absorption caused by blood pulsation in the vascular bed, which are used to determine SpO₂ and PR. It contains light-emitting diodes (LEDs) and a photodetector, with the photodetector positioned on the opposite side of the probe from the LEDs. SpO₂ and PR are displayed on the device's LED/OLED screen, providing a visual pulse indicator that blinks in sync with the detected PR.
The Oximeter is powered by two AAA alkaline batteries and does not feature alarms. The YX310 and YX110 models can transfer data to a mobile device wirelessly whereas the YX105 and YX106 models do not transfer data.
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