Clear statement: The smart health devices sold on this site — including smart blood glucose monitors, smart blood pressure monitors, smart body composition scales, and smart wristbands — are NOT medical devices. They are not intended for the diagnosis, treatment, prevention, or monitoring of diseases. Data provided by these devices is for general wellness and lifestyle reference only and cannot replace professional medical advice. If you feel unwell, please seek timely medical attention from a qualified healthcare provider.
Product Positioning and Intended Use
- Smart health products on this site are designed to support everyday wellness awareness, such as tracking activity levels, observing weight trends, and understanding daily routines.
- These products do not meet the functional definition of medical devices. Their measurements do not constitute clinical diagnostic evidence and should not serve as the sole basis for medication decisions, treatment plan adjustments, or medical consultation choices.
- All product function descriptions should be understood within the scope of general wellness lifestyle tools, not medical applications.
FDA Safety Warning on Unauthorized Blood Pressure Devices
On September 16, 2025, the U.S. Food and Drug Administration (FDA) issued a safety communication explicitly warning consumers against using blood pressure measurement devices that have not been authorized by the FDA, including smartwatches and smart rings with blood pressure software features. The FDA stated that these devices have not undergone safety and effectiveness review, and inaccurate readings could lead to serious consequences including stroke and heart attack. The FDA recommends that consumers verify authorization status by searching product code DXN in the 510(k) database (Source: U.S. FDA Safety Communication, 2025-09-16).
The smart blood pressure monitors and other health monitoring devices sold on this site have not been claimed to hold FDA 510(k) authorization. Do not use readings from these products as a basis for medical decisions.
Usage Recommendations
- Treat smart health devices as lifestyle reference tools, not medical instruments.
- For accurate physiological measurements, use certified medical equipment under professional guidance.
- If monitoring data appears abnormal, visit a healthcare facility for professional evaluation rather than self-interpreting or relying solely on device readings for health decisions.
- Users with chronic conditions or those undergoing treatment should follow their physician’s guidance for health management. Smart device data cannot replace professional medical advice.
Related Compliance Information
For our product compliance and safety statements, please review the Product Compliance and Safety page. For information on how personal health data is handled, please see our Privacy Policy. Information is current as of September 2026 and subject to official updates.