Understanding Where Throne Fits in Your Health Journey
Throne was designed to make gut health and hydration awareness effortless. It helps you understand your body better through automated, passive monitoring that turns daily moments into meaningful health insights.
It is important to be clear about what Throne is, and what it is not.
Throne Is a Wellness Device
Throne is classified and marketed as a general wellness product, not a medical or diagnostic device.
That means it is built to support healthy habits and awareness, not to diagnose, treat, cure, or prevent disease.
Think of it like a sleep tracker or fitness wearable. It gives you new data about your body, in this case your digestion and hydration, so you can make informed daily decisions that improve how you feel.
What a Wellness Device Does
Throne’s features are designed to promote awareness, prevention, and healthier daily choices.
Monitors patterns over time: Tracks bowel movement frequency, stool consistency, and urine characteristics.
Shows trends and baselines: Compares today’s data with your usual pattern so you can see what is changing.
Provides insights for self-care: Offers visual summaries and wellness-oriented suggestions to help you understand your habits.
All of these features are focused on self-awareness and habit improvement within the scope of general wellness.
What a Medical Device Would Do (And Why Throne Is Not One)
Medical devices are regulated by the U.S. Food and Drug Administration (FDA) when they are intended to diagnose, monitor, or treat a medical condition.
For example, colonoscopy systems, glucose monitors, or home urinalysis kits that detect disease markers require FDA clearance before they can be sold.
Throne does not make diagnostic or therapeutic claims. It does not test for pathogens, detect disease, or provide medical interpretations. Instead, its algorithms analyze visual and pattern-based data, such as stool consistency and hydration levels, to help you recognize trends and make small adjustments in your daily routine.
Has Throne Been Cleared or Approved by the FDA
No. Throne One has not been cleared or approved by the U.S. Food and Drug Administration (FDA) or any other regulatory body at this stage because it is not required for its current purpose as a general wellness device.
Throne’s design and development process follow high standards for safety, data privacy, and accuracy. Each feature is developed through human-centered design and validated with internal testing before release.
Future versions of Throne may include regulated capabilities, such as diagnostic or clinical testing modules. If those features are added, they will go through the required FDA review and approval process before launch.
Why This Distinction Matters
Understanding how Throne is classified helps you make the right decision for your health goals.
If You Want To… | Throne Can Help You… | Throne Cannot (Yet) Replace… |
Understand your gut and hydration patterns | Track stool and urine characteristics automatically | Clinical tests or medical diagnosis |
Manage lifestyle factors | Identify trends related to diet, stress, or hydration | Prescribed treatments or lab results |
Bring better data to your doctor | Export and share visual summaries | Professional medical evaluation or decision-making |
In short, Throne empowers awareness, while your doctor interprets health.
The Bottom Line
Throne One is a general wellness device that helps you listen to your body in new ways. It operates automatically, privately, and without effort.
It is not a medical device and does not replace professional care. Instead, it complements your health journey by helping you stay informed, proactive, and connected to the signals your body gives every day.
Throne provides general wellness insights and is not intended to diagnose, treat, cure, or prevent any disease.