Exclusive Interview | China's First Class III Certificate! Innovative TCM Medical Device Pushes Forward with FDA and CE International Certification

Geographically, a line stretches from Henan in the heartland of China's Central Plains to Hengqin on the shores of the South China Sea: the photovoltaic base in Lankao, Henan, supplies 100% green electricity capacity, aligning with EU carbon standards; meanwhile, the subsidiary in Hengqin leverages global market access. By replacing traditional Chinese medicine's reliance on "individual renowned physicians' experience" with the certainty of industrial standardization, this innovative TCM medical device company charts its path forward.

Recently, Henan Lixinghe Medical Technology Co., Ltd. (hereinafter referred to as "Lixinghe") independently developed a TCM medical device—the acupoint microwave stimulation device—which has passed the full-process review by the NMPA and obtained the Class III Medical Device Registration Certificate (Registration Certificate No. 国械注准20263201213), becoming China's first approved Class III TCM medical device.

Previously, most TCM therapeutic devices remained within the Class II "adjunctive physiotherapy" category, with relatively limited standardization, which significantly constrained their recognition and promotion among frontline practitioners.

According to the "Medical Device Classification Catalog," the only Class III management category for TCM devices is TCM treatment equipment—specifically, acupoint microwave stimulation devices. These devices typically consist of a main unit and a microwave radiator. The microwave radiator is sized appropriately for non-invasive application to acupoints, utilizing microwave energy to stimulate human acupoints and produce effects similar to acupuncture. In short, this is a highly standardized "non-invasive" microwave acupuncture therapeutic device.

The approved indication is "Relief of Pain in Periarthritis of the Shoulder." It is reported that the "Acupoint Microwave Stimulation Device" is undergoing registration changes for indications such as limb motor dysfunction following ischemic stroke and chronic fatigue syndrome. Meanwhile, clinical research is being conducted on various difficult-to-treat conditions, including rheumatoid arthritis, pediatric cerebral palsy, Parkinson's disease, and ALS.

After three generations of relay efforts and more than thirty years of in-depth cultivation, Lixinghe has leveraged dozens of core international patents to translate the ancient wisdom of acupuncture into the standardized language of evidence-based medicine. At this critical juncture, VCBeat presents an exclusive interview with Zhang Yanming, Chairman of Lixinghe, on how innovative TCM devices are driving standardized treatment and what progress high-end TCM therapeutic devices have made in going global with FDA and CE certifications.

The genesis of Lixinghe stems from the ancestral philosophy, established three decades ago, that "TCM should not be limited to empirical practice." At that time, microwave technology was merely a set of cold industrial parameters, while TCM meridians remained mired in metaphysical controversies due to the difficulty of quantification. Zhang Yanming's grandparents specialized in microwave engineering, while her father's generation dedicated themselves to clinical TCM practice. Now, leading the third generation, she founded Lixinghe to integrate microwave technology with TCM acupuncture. The company has launched standardized, evidence-based innovative medical devices for TCM, promoting high-end innovative TCM treatment equipment to a global market.

The pain points of TCM lie in the difficulty of quantifying efficacy and standardizing treatment protocols. Zhang Yanming emphasizes, "By integrating science and technology with TCM, we can transform acupuncture-based therapies into replicable, process-driven product formats, thereby achieving standardized, streamlined, and user-friendly TCM treatments."

Publicly available information indicates that the "Acupoint Microwave Stimulation Device" integrates TCM acupoint theory with modern microwave technology. It utilizes microwave energy to act on relevant acupoints in the shoulder region and is indicated for the relief of pain associated with scapulohumeral periarthritis. This device is intended for use in medical institutions and must be operated by physicians specializing in TCM.

From a technical core perspective, the "acupoint microwave stimulation device" is based on an array composed of multiple microwave radiators. It controls the focusing and attenuation of multi-source energy through optimization algorithms—allowing microwaves to take full effect at subcutaneous acupoints, thereby "translating" the traditional Chinese medicine experience of locating acupoints and achieving De Qi into quantifiable electromagnetic field algorithms.

Meanwhile, Lixinghe has standardized acupuncture treatment protocols—including acupoint selection, treatment courses, and dosage—into built-in standardized menus on its product devices, thereby reducing reliance on traditional manual techniques and empirical experience.

Returning to the essence of innovative medical devices, safety, efficacy, and compliance are the key pillars for clinical promotion and market acceptance.

Lixinghe's device is positioned as a therapeutic medical device. The prototype has been in clinical use since 1990, with over a thousand cases recorded in hospital settings.

The accumulation of real-world treatment data has laid a solid clinical foundation for Lixinghe. However, relying solely on empirical experience is far from sufficient to secure the first domestic registration certificate for a Class III TCM therapeutic device. Comprehensive animal studies, standardized registrational clinical trials, and clear mechanistic research are the core pillars supporting the pathway to regulatory compliance.

In terms of safety, the "Acupoint Microwave Stimulation Device" has completed animal testing validation in accordance with regulations. Regarding clinical registration, the device has completed clinical trials for periarthritis of the shoulder and has simultaneously obtained the Class III Medical Device Registration Certificate from the NMPA.

In terms of standardization, the "Acupoint Microwave Stimulation Device" incorporates a comprehensive treatment protocol integrating acupoints and microwave therapy, along with standardized operating procedures. This product is suitable for shared use across multiple departments, including Rehabilitation, Pain Management, TCM, and Preventive TCM Care.

Since 2021, Lixinghe has continuously built a patent matrix around its acupoint microwave stimulation device, establishing a comprehensive portfolio that covers probes, concentrators, complete system integration, and intelligent software. Starting in 2023, Lixinghe initiated its overseas patent strategy, securing international patent families in the United States, the European Union, Japan, and South Korea, and has commenced preparation for FDA and CE certification applications.

Microwave technology has become a mature category in the global medical device market, with technical pathways utilized in Europe and the United States for over a century. Numerous overseas companies are developing innovative microwave-based devices, leveraging thermal effects for applications such as wound healing and anti-inflammatory treatments. In contrast, Lixinghe's competitive differentiation lies in its TCM therapeutic approach, which achieves efficacy through acupoint and meridian responses within the non-thermal effect window.

The FDA currently has no independent classification for "therapeutic TCM devices," necessitating a De Novo classification request, which entails a high barrier to entry. As the inaugural move in its overseas expansion strategy, Lixinghe's subsidiary, "Lihe Haichuang," has officially established its presence in the Hengqin Guangdong-Macao In-Depth Cooperation Zone in the Greater Bay Area. Leveraging Hengqin's unique locational and policy advantages, Lihe Haichuang will fully capitalize on the long-standing and robust economic and trade ties between Macao and Portuguese-speaking countries (including Brazil, Angola, Mozambique, Portugal, etc.), serving as a strategic bridgehead for entering international markets.

Notably, many Portuguese-speaking countries rank among the highest globally in their acceptance of TCM. In Brazil, for instance, the Acupuncture Association has a history spanning over 50 years. Acupuncture therapy is not only covered by the national health insurance system but also included in the official list of alternative therapies, establishing a robust market foundation. This first-mover advantage provides Lihe Haichuang with a natural strategic foothold to penetrate the Portuguese-speaking market, using TCM services as its entry point.

Compared to mainstream markets in Europe and the United States, Portuguese-speaking countries and BRICS nations, where TCM enjoys higher acceptance, present lower market entry barriers and enable more efficient initial promotion. This product employs a non-invasive, external operation method with built-in standardized algorithms, eliminating dependence on the local availability of TCM practitioners and thereby lowering the promotional threshold for local distributors.

In terms of production capacity, Lixinghe is headquartered in the Lankao Economic and Technological Development Zone, covering a total area of 200 mu. The base is equipped with a megawatt-scale photovoltaic power station, ensuring that future all-green-electricity production complies with EU carbon standards for exports. Currently, the first phase of the 10,000-square-meter factory building has been completed and is ready for production, gradually evolving into a modern integrated base for R&D, manufacturing, testing, and warehousing.

On the left is Hengqin's "institutional export gateway," and on the right is Henan Lankao's "fully green electricity production base." In 2026, the global expansion of TCM no longer repeats the soft narrative of "cultural export," nor does it need to fall into the old path of "only entering overseas clinics." The new paradigm proposed by Lixinghe is: hard-tech therapeutic devices + globally universal clinical value + low-threshold replication and promotion.

Note: For contraindications or precautions, please refer to the product instructions.