The global gold standard for medical devices – FDA certification
2026-09-16
Dear Valued Partner,
We are very pleased to share some exciting news with you:
YMHeart Wearable ECG Recorder has officially received FDA 510(k) Clearance (K254119)in September 11,2026。
Why YMHeart?This is an important milestone for YMHeart and a strong recognition of our innovative wearable ECG technology. We are now actively looking for distributors, agents, and strategic partners worldwide to bring this innovative solution to more markets and create long-term mutual value together.
Our wearable ECG recorder is designed to redefine the possibilities of long-term ambulatory ECG monitoring.
Key advantages include:
● No charging required – designed for continuous monitoring without the inconvenience of frequent charging.
● Real waterproof design – patients can wear the device during daily activities, including showering.
● 7–14 days of continuous ECG monitoring – supporting long-term cardiac monitoring and improving the chance of capturing intermittent cardiac events.
● Multiple lead configurations – different patch/lead options are available for different clinical and application scenarios.
● Telemetry mode available – supporting real-time data transmission and remote monitoring applications.
● RMP / Remote Patient Monitoring – enabling new possibilities for remote cardiac care and digital health services.
● Comfortable wearable design – developed with the goal of making long-term ECG monitoring more convenient for both healthcare professionals and patients.
We believe these advantages can provide a powerful solution for hospitals, clinics, diagnostic centers, telemedicine providers, remote patient monitoring programs, and other healthcare applications.
More Than a Product – A Long-Term Partnership
YMHeart is not simply a trading company.
We are an R&D-driven medical technology company with our own product development and manufacturing capabilities. We have the technology, engineering expertise, manufacturing capacity, and flexibility to work closely with partners in different markets.
We sincerely welcome partners who are interested in building the wearable ECG and remote cardiac monitoring market together with us.
We are open to working with local distributors, medical device companies, healthcare solution providers, telemedicine companies, and strategic partners.
Our goal is not simply to sell products.
We want to build markets together, develop applications together, and achieve long-term win-win cooperation.
If you are interested in becoming our local distributor, agent, or strategic partner, we would be delighted to discuss market opportunities, product configurations, cooperation models, and technical support with you.
Certification Quick Overview：
FDA 510(k) Clearance: K254119
product name：Wearable ECG Recorder
Approved model：YMHeart XY-12 / XY-1201 / XY-1202 / XY-1203 / XY-03 / XY-0301 / XY-0302 / XY-0303
We believe this is just the beginning.
Let’s work together to bring smarter, more convenient, and more accessible cardiac monitoring solutions to patients around the world.
We look forward to hearing from you and exploring opportunities for cooperation.
Best regards,
![The global gold standard for medical devices – FDA certification 1]()
We are very pleased to share some exciting news with you:
YMHeart Wearable ECG Recorder has officially received FDA 510(k) Clearance (K254119)in September 11,2026。
Why YMHeart?This is an important milestone for YMHeart and a strong recognition of our innovative wearable ECG technology. We are now actively looking for distributors, agents, and strategic partners worldwide to bring this innovative solution to more markets and create long-term mutual value together.
Our wearable ECG recorder is designed to redefine the possibilities of long-term ambulatory ECG monitoring.
Key advantages include:
● No charging required – designed for continuous monitoring without the inconvenience of frequent charging.
● Real waterproof design – patients can wear the device during daily activities, including showering.
● 7–14 days of continuous ECG monitoring – supporting long-term cardiac monitoring and improving the chance of capturing intermittent cardiac events.
● Multiple lead configurations – different patch/lead options are available for different clinical and application scenarios.
● Telemetry mode available – supporting real-time data transmission and remote monitoring applications.
● RMP / Remote Patient Monitoring – enabling new possibilities for remote cardiac care and digital health services.
● Comfortable wearable design – developed with the goal of making long-term ECG monitoring more convenient for both healthcare professionals and patients.
We believe these advantages can provide a powerful solution for hospitals, clinics, diagnostic centers, telemedicine providers, remote patient monitoring programs, and other healthcare applications.
More Than a Product – A Long-Term Partnership
YMHeart is not simply a trading company.
We are an R&D-driven medical technology company with our own product development and manufacturing capabilities. We have the technology, engineering expertise, manufacturing capacity, and flexibility to work closely with partners in different markets.
We sincerely welcome partners who are interested in building the wearable ECG and remote cardiac monitoring market together with us.
We are open to working with local distributors, medical device companies, healthcare solution providers, telemedicine companies, and strategic partners.
Our goal is not simply to sell products.
We want to build markets together, develop applications together, and achieve long-term win-win cooperation.
If you are interested in becoming our local distributor, agent, or strategic partner, we would be delighted to discuss market opportunities, product configurations, cooperation models, and technical support with you.
Certification Quick Overview：
FDA 510(k) Clearance: K254119
product name：Wearable ECG Recorder
Approved model：YMHeart XY-12 / XY-1201 / XY-1202 / XY-1203 / XY-03 / XY-0301 / XY-0302 / XY-0303
We believe this is just the beginning.
Let’s work together to bring smarter, more convenient, and more accessible cardiac monitoring solutions to patients around the world.
We look forward to hearing from you and exploring opportunities for cooperation.
Best regards,
ReviewsNumber of comments: {{ page.total }}
I want to comment?
{{item.nickname ? (item.nickname.slice(0, 2) + '*****') : item.source === 1 ? 'mall buyer' : '--'}}
{{item.comment_time}}
Review in the {{item.country}}
Reviews
Merchant
{{replyItem.nickname ? (replyItem.nickname.slice(0, 2) + '*****') : replyItem.source === 1 ? 'mall buyer' : '--'}}
{{replyItem.parent_nickname ? (replyItem.parent_nickname.slice(0, 2) + '*****') : '--'}}
{{replyItem.is_merchant_reply === 1 ? replyItem.reply_time : replyItem.comment_time}}
Review in the {{replyItem.country}}
Reviews
No customer reviews
Get in touch with us
Yuhan Global Limited is dedicated to advancing global cardiac health monitoring and telemedicine diagnostics, delivering reliable, accessible and innovative ECG solutions to improve healthcare access for patients around the world.
Useful Links
Products
Contact Us
Contact person: susan
Tel: +86 134 3712 3829
Email: susan@yuhanglobal.com
WhatsApp: +86 134 3712 3829
Add:
Room a5,7/f, astoria building, no.34 ashley road, tsim sha tsui, hong kong