Bluetooth ECG Health Watch Solution Powered by H Band
Smart, Stylish, and Focused on Real Health Insights
At Wonlex, we believe wearable technology should do more than just count steps — it should deliver actionable, real-time health data that matters. That’s why we’ve developed our Bluetooth ECG Health Watch Solution, integrating trusted biosensor hardware with the powerful H Band app, offering accuracy, ease of use, and customization flexibility for partners and brands worldwide.
Advanced Health Monitoring at Your Fingertips
Powered by the Goodix 3228T ECG chip, our health-focused Bluetooth watch is designed for users who want more than just fitness — they want confidence in their vitals. This chip, paired with PPG sensors and advanced optical modules, enables:
ECG + PPG Monitoring
Get real-time data on heart rhythm and blood flow through combined ECG (electrocardiogram) and PPG (photoplethysmography) technologies. While the Standard models offer basic, helpful heart data for wellness tracking. For higher precision or medical-grade measurements, customized hardware with higher-end sensors is required.
Blood Pressure Monitoring
Available in air-pump versions only for more accurate results. Non-pump optical BP is for reference only.
SpO₂Monitoring. Monitors blood oxygen saturation using red + infrared light.
Blood Glucose Estimation. Offers trend insights —Not intended for clinical diagnosis.
Sleep Monitoring. Tracks sleep stages and quality throughout the night.
Activity Tracking & Multi-Sport Modes. Step counting, calorie burn, and workout summaries for active lifestyles.
Stay Connected with Smart Functions
Bluetooth Calling Support. Make and receive calls directly from your wrist via Bluetooth.
Smart Notifications. Instantly get alerts for calls, messages, and apps.
Music Control & Remote Camera. Control your phone’s playlist or snap photos remotely.
H Band App – Trusted Companion for Health Data
Our watch pairs with the H Band app, one of the most reliable platforms for Bluetooth ECG health devices. The app provides:
Clean, intuitive ECG wave playback
Health trend graphs (ECG, HR, BP, SpO₂, etc.)
Historical reports and data export
User-friendly interface in multiple languages
Sync with cloud storage or third-party platforms
SDK & OEM/ODM Customization Services
Looking to build your own brand or integrate wearable health data into your existing platform? We offer:
SDK/API for data integration
Perfect for insurance, health apps, or custom dashboards.
OEM Services
Device branding
Logo & packaging customization
Strap/color/style options
ODM Services
New design and sensor integration
App/UI customization
Firmware optimization
Whether you're a healthcare startup, wellness brand, or distributor, we provide full technical and design support to help you build a tailored, health-focused solution.
Medical Certification Status
Our Bluetooth ECG health watches are designed for wellness and lifestyle monitoring, not for clinical diagnosis or medical treatment.
Do these watches hold medical certifications like FDA 510(k), MDR, or NMPA?
All models currently available for sale globally are not certified under:
FDA 510(k) (U.S.)
MDR (EU Medical Device Regulation)
NMPA (China’s National Medical Products Administration)
In China, we offer customized ECG models that have passed NMPA certification, suitable for domestic medical-use scenarios.
What Do These Certifications Mean?
FDA 510(k) (U.S.):
A premarket submission to the U.S. FDA proving that a device is substantially equivalent to a legally marketed medical device. Required for selling medical-grade ECG wearables in the U.S.
MDR (EU):
The European Medical Device Regulation ensures that products are safe and effective for medical use in Europe. It requires clinical evaluation and quality system compliance.
NMPA (China):
China's medical device regulatory authority. Devices claiming diagnostic health functions must undergo technical evaluation, risk testing, and safety compliance to receive certification.
Important Note for Buyers and Partners
Current models sold internationally are classified as general wellness products, not medical devices.
For projects requiring clinical-grade or certified ECG wearables, we offer ODM customization with hardware upgrade options.
At this time, we do not provide support for FDA 510(k) or MDR certification, due to the high cost, long regulatory timelines, and strict regional compliance requirements.
Download EU DoC for H Band (PDF)
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