Tag: fda

On January 6, 2026, the U.S. FDA issued an updated “General Wellness: Policy for Low Risk Devices” guidance document, replacing the 2019 version. This guidance explicitly clarifies for the first time that wearable devices monitoring physiological parameters such as blood pressure, blood glucose, and blood oxygen may be exempt from medical device regulation under specific conditions. According to Troutman Pepper law firm’s analysis, this update responds to industry controversy following the FDA’s July 2025 warning letter to WHOOP, which determined that its “Blood Pressure Insights” feature constituted an unapproved medical device.

Exemption Conditions and Compliance Boundaries

According to the guidance, wearable devices must simultaneously meet the following conditions to qualify for the “general wellness” exemption:

• Non-invasive sensing: Data collection methods must not penetrate the skin or enter the body. This means transmissive sensors such as fingertip pulse oximeters may not qualify for the exemption, while reflective optical sensors on the back of a watch may meet the criteria.
• Claims limited to “general wellness” purposes: Marketing materials must not claim the ability to diagnose, treat, prevent, or mitigate any disease. Language should be confined to categories such as “healthy lifestyle support” or “promoting physical wellness awareness.” Even technically accurate descriptions may trigger regulatory scrutiny if they imply a disease association.
• No disease association: Even if a product is technically capable of detecting a physiological abnormality, associating that abnormality with a specific disease may result in classification as a medical device. The WHOOP case serves as a typical cautionary example: although the product was positioned as a “health tracker,” the naming and marketing of its “Blood Pressure Insights” feature implied an association with hypertensive disease, leading the FDA to classify it as an unapproved medical device.

Reference Value for Consumers

This guidance provides consumers with a framework for evaluation: when a wearable device’s claimed functions extend beyond the “general wellness” scope into the realm of disease diagnosis or treatment, it should hold appropriate medical device authorization. If a product makes medical-related claims without such authorization, consumers should exercise caution. At the same time, data from compliant “general wellness” devices still holds reference value, though it should not be treated as a substitute for medical diagnosis.

Important Disclaimer: The Smart Blood Glucose Meter GL1, Smart Electronic Blood Pressure Monitor BM1, Smart Body Fat Scale B1, Smart Band H1, and Smart Band H2 sold on this site are not medical devices. They are not intended for diagnosis or treatment of any disease. Data collected by these products is provided solely for general wellness and lifestyle reference purposes. If you feel unwell, please consult a healthcare professional. Our products are positioned as healthy lifestyle support tools and do not constitute medical advice. For specific product information, please refer to the product detail pages. Compliance and safety details are available on our Product Compliance and Safety page.

Information current as of September 2026. Please refer to official sources for the latest updates.

参考来源 / Sources

• U.S. FDA / Troutman Pepper Law Firm Analysis, 2026-01-06, FDA’s 2026 Guidance on General Wellness Devices

---

On September 16, 2025, the U.S. Food and Drug Administration (FDA) issued a safety communication warning consumers against using blood pressure measuring devices that have not been authorized by the FDA. The FDA explicitly stated that such devices, including blood pressure software features embedded in smartwatches and smart rings, have not undergone FDA review for safety and effectiveness. Inaccurate readings could lead users to delay seeking medical care, potentially resulting in serious consequences such as stroke or heart attack.

Key FDA Recommendations

In its communication, the FDA advises consumers to search for product code DXN in the 510(k) database to verify whether a specific blood pressure measuring device has received FDA authorization. Only devices that have passed 510(k) review and obtained authorization may legally be marketed in the United States as blood pressure measuring medical devices.

This communication was prompted by the growing number of consumer wearable devices on the market claiming blood pressure measurement capabilities, many of which have not gone through the medical device approval process. The FDA’s action aims to help consumers distinguish between “health monitoring features” and “medical diagnostic functions.” Importantly, the FDA’s warning targets devices that claim blood pressure measurement capability without authorization, not all wearable health products.

How Consumers Should Evaluate

Faced with a wide variety of blood pressure-related products, consumers can consider the following approach:

• Distinguish intended use: If a product claims it can be used to diagnose, treat, or monitor conditions such as hypertension, it should have obtained FDA 510(k) authorization. Products making such claims without authorization carry compliance risks, and consumers should exercise caution.
• Verify authorization status: Searching product code DXN in the FDA 510(k) database can confirm whether a specific device appears on the authorized list. This is a publicly accessible database that consumers can search independently.
• Interpret health data rationally: Data provided by health monitoring devices that lack medical device authorization should serve only as lifestyle references and should not form the basis for medical decisions. Even if data shows abnormalities, confirmation through proper medical channels is recommended.

Important Disclaimer: The Smart Blood Glucose Meter GL1, Smart Electronic Blood Pressure Monitor BM1, Smart Body Fat Scale B1, Smart Band H1, and Smart Band H2 sold on this site are not medical devices. They are not intended for diagnosis or treatment of any disease. Data collected by these products is provided solely for general wellness and lifestyle reference purposes. If you feel unwell, please consult a healthcare professional. These products have not received FDA 510(k) authorization and must not be used as substitutes for professional medical equipment. For specific product information, please refer to the product detail pages. Compliance and safety details are available on our Product Compliance and Safety page.

Information current as of September 2026. Please refer to official sources for the latest updates.

参考来源 / Sources

• U.S. Food and Drug Administration (FDA), 2025-09-16, Do Not Use Unauthorized Devices for Measuring Blood Pressure

---