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