About

Our factory is a high-tech enterprise specializing in the R&D, production, and sales of TENS (Transcutaneous Electrical Nerve Stimulator), EMS (Electrical Muscle Stimulator), and related physiotherapy accessories. With over a decade of experience in the medical and health field, we are committed to providing global clients with compliant, high-quality, and cost-effective physiotherapy equipment solutions. Leveraging stringent quality control, a complete certification system, strong R&D and customization capabilities, and professional cross-border services, we have become a core partner of well-known brands in Europe, America, Australia, Southeast Asia, and other regions worldwide, with products exported to over 50 countries and regions.

Regarding compliance and certification, we have pioneered a full-chain certification system that meets international standards: the factory holds a domestic medical device production license, and our core products have passed US FDA 510(k) registration/listing and EU MDR 2017/745 CE certification (including certificates issued by notified bodies). We also fully comply with RoHS, REACH, and other hazardous substance restriction standards. Regional certifications such as the Australian TGA and Brazilian ANVISA can be quickly assisted in completing the registration process, ensuring smooth entry into mainstream global markets.

Quality is the lifeline of our enterprise. We have established a comprehensive quality control mechanism centered on the ISO 13485 medical device quality management system. Equipped with a professional quality control team, we strictly implement three key stages: Incoming Quality Control (IQC), In-Process Quality Control (IPQC), and Finished Product Quality Control (FQC). We regularly issue reliability reports, including electrode adhesion tests, wire bending tests, and main unit aging tests. Our factory boasts an independent R&D team and core component development capabilities, enabling us to customize product functions (number of modes, intensity levels), appearance design, and packaging solutions according to customer needs. We independently control core technologies such as electrode hydrogel formulations and main unit control chip solutions, ensuring product quality stability and superior performance.

Our production supply chain is robust. We have a modern production base equipped with multiple automated production lines (electrode die-cutting machines, main unit assembly lines, etc.). The electrode production process utilizes a cleanroom, meeting medical-grade production environment requirements. Our factory boasts flexible production capacity, capable of fulfilling customized orders of 500-5000 units with a minimum order quantity (MOQ). Delivery time for orders under 10,000 units is controlled within 30-45 days. We have established a safety stock system for core components and forged long-term strategic partnerships with high-quality chip and battery suppliers, effectively mitigating supply disruption risks and ensuring efficient order delivery.

We understand the core needs of cross-border cooperation and have assembled a professional foreign trade service team capable of providing multilingual communication services in English, Spanish, German, and other languages. We assist clients throughout the process of arranging sea/air freight and provide complete customs clearance documents, including commercial invoices, packing lists, certification certificates, and certificates of origin. For after-sales service, we promise a 1-2 year product warranty and guarantee timely supply of spare parts, completely eliminating any concerns for our clients. In business cooperation, we support commonly used overseas payment methods such as letters of credit (L/C) and wire transfer (T/T), offering flexible payment terms (e.g., 30% deposit + 70% balance). Free samples are available (sample fees are refunded after large orders), with sample delivery time controlled within 7-15 days.

Furthermore, we prioritize intellectual property protection and social responsibility, holding numerous product design and utility model patents. We can sign confidentiality agreements to protect the security of customized designs and business information for our clients. We are also BSCI/SEDEX certified, ensuring that our labor practices and environmental practices meet international standards. With extensive experience in OEM/ODM manufacturing for renowned international brands and a comprehensive product lifecycle traceability system (each product is equipped with a unique serial number), we have earned the widespread trust of our global clients.

Our factory adheres to the principles of “compliance first, quality foremost, and customer supremacy,” and we look forward to collaborating with partners in the global healthcare industry to create shared value!