Comment from LifePlus, Inc

AnonymousOtherBusiness
Summary: Ben Mbouombouo, Co-Founder of LifePlus Inc, is seeking clarification on whether specific biomarkers (blood glucose, blood pressure, oxygen saturation, and respiration rate) can be displayed on a general wellness device. He notes that these values are intended solely for wellness purposes like weight management and sleep management, rather than for disease diagnosis.
To Whom It May Concern, With regard to the published General Wellness: Policy for Low Risk Devices, I have the following questions regarding the display of biomarker values in a general wellness device that is labelled "do not use for any disease diagnosis": Can blood glucose values (e.g., 95 mg/dL) be displayed? Can blood pressure values (e.g., 118/75 mmHg) be displayed? Can oxygen saturation values (e.g., 98%) be displayed? Can respiration rate values (e.g., 15 breaths/min) be displayed? These biomarkers are intended solely for general wellness purposes, such as weight management, physical activity scoring, and sleep management. Metabolic Intelligence • Glucose estimation & trends • Metabolic Time-in-Range • Metabolic scorecard • Metabolic flexibility & variability Cardiovascular Intelligence • Blood pressure trends & hypertension detection • Cardiovascular age estimation • Continuous ECG analytics • Cardiorespiratory fitness scoring Sleep & Recovery Intelligence • Sleep quality scoring • Sleep pattern analysis • Sleep apnea detection • Recovery / readiness score Stress & Autonomic Intelligence • Stress level estimation • Autonomic balance (sympathetic/parasympathetic) • Fatigue & recovery dynamics Emotional & Cognitive State • Emotional state (valence, arousal) • Mood trends (longitudinal) • Cognitive load / resilience System-Level Intelligence (Differentiator) • Cross-biomarker correlations • Longitudinal health trajectory modeling • Early risk prediction (cardio-metabolic events) • Personalized baseline modeling Thanks and Regards, Ben Mbouombouo Co-Founder LifePlus Inc San Jose, CA 95126 w: www.lifeplus.ai

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