FDA Approves WBP-02A: Hingmed ABPM Gold Standard Redefined

Hingmed WBP-02A has passed FDA, now standing at the leading position in the ABPM industry.

The U.S. Food and Drug Administration (FDA) ensures the safety and accuracy of human and veterinary medicines, biologics, and medical devices. Blood pressure monitors must receive FDA (510k) marketing clearance to be legally marketed and sold in the U.S. WBP-02A 24-hour ABPM is a 510(k) cleared, non-invasive device used for 24-hour blood pressure monitoring. The FDA approval of WBP-02A means that WBP-02A’s safety, accuracy, consistency, and stability have been evaluated and authorized by the FDA.

FDA Approves WBP-02A: Hingmed Leads ABPM Globally
WBP-02A’s 24-hour ABPM accuracy and consistency have been acknowledged by the U.S. Food and Drug Administration (FDA). It makes a significant milestone for China’s ambulatory blood pressure monitor technology. This achievement highlights Hingmed’s growing leadership in high-accuracy diagnostic blood pressure devices.
Hingmed motion tolerance technology: good measurement consistency even in ambulatory circumstances.
Clinical level: WBP-02A is evaluated in a general population according to the ISO 81060-2:2018 protocol, and clinically validated to the European Society of Hypertension International Protocol revision 2010.
No air tube: Comparing traditional ABPM, Hingmed WBP-02A is directly worn on the upper arm without an air tube.
Body position record: Hingmed WBP-02A provides accurate and consistent blood pressure measurements with body movement, including sit/stand, lying, light movements, and heavy movements.
WBP-02A has also been recommended by the European Society of Hypertension (ESH), British and Irish Hypertension Society (BIHS), and listed in Dabl Educational Trust and STRIDE BP. These endorsements further reinforce WBP-02A’s clinical credibility and global recognition.

About Hingmed
Founded in 2014, Hingmed specializes in blood pressure monitoring and respiratory technologies and products for over 12 years. Our ambulatory blood pressure monitor, WBP-02A, has already appointed an exclusive distributor in the UK, where thousands of ABPMs have been successfully implemented in pharmacies and healthcare settings. We welcome distributors who are passionate about medical devices. Hingmed provides exclusive agent support and a long-term partnership.