NAME OF DEVICE	IHEALTH WIRELESS PULSE OXIMETER
ESTABLISHMENT NAME	ADS ON NETWORK SDN BHD
ROLE OF ESTABLISHMENT	AUTHORIZED REPRESENTATIVE
REGISTRATION NO	GB10225026-226568
BRAND NAME	IHEALTH
MEDICAL DEVICE CATEGORY	MD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPE	SYSTEM
DEVICE DESCRIPTION	The PO3M pulse oximeter measures the amount of oxygen in your blood and the pulse rate. The oximeter works by shining two light beams into the finger's small blood vessels or capillaries; the measured signal is then obtained by a photosensitive element and processed by the microprocessor. The oxygen saturation (SpO2) is measured as a percentage of full capacity. Typically, an SpO2 reading between 94%-99% is considered normal. High altitudes and other factors may affect what is considered normal for a given individual. Concerns about your readings should be shared with your physician or healthcare professional.
DEVICE INTENDED PURPOSE	The PO3M Wireless Pulse Oximeter is a non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Wireless Pulse Oximeter is intended to measure blood oxygen saturation and pulse rate of adults above 16 years old in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care, etc.). The Wireless Pulse oximeter is not intended for continuous monitoring.
VALIDITY DATE OF REGISTRATION	24/02/2026 - 23/02/2031

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