JKH Company Profile
Background
Founded in 2003 with about 200 patients, JKH specializes in the R&D, production and sales of Class I/II/III medical devices. We hold a leading position in the pneumatic compression and cold therapy market, and have years of experience in ultrasound therapy and different braces. We mainly use two manufacturing facilities to fulfill orders from customers worldwide: one in China, and the other in Cambodia.
Our certifications include FDA PMA (Class III), FDA 510(k) (Class II), CE Medical (Class II), Health Canada (Class II), INMETRO (Class II) and CFDA (Class II). Our management systems are certified to MDSAP, ISO13485, GMP and WCA.
China-Based Factory
Based on Dongguan, China, our factory offers the full‑process production: fabric cutting, high‑frequency welding, sewing, assembly and air‑tightness testing. Our patented Cryon‑X® cryotherapy device is sold worldwide via local partners.
Following ISO13485 and FDA QSR820 standards, we conduct batch inspections to fulfill large overseas orders. We maintain long‑term cooperation with medical clients across Europe, America and Latin America. We will strengthen the international collaboration to supply high‑performance medical devices globally.
US-Based Office
Based in California, our US-based office provides the convenient service to overcome the time zone difference. With bases in the US and Asia, we are 24 hours online, addressing your need anytime anywhere.
With manufacturing experience of over 20 years, we can offer the one-stop OEM & ODM service, supporting product development and mass production to deliver high-quality solution globally.
Cambodia-Based Factory
Based in Cambodia, our manufacturing facility has the solid experience in the comprehensive production capabilities. The factory undertakes high-frequency welding, sewing process, and electronic product assembly. We excel at producing medical devices, and also manufacture sewn products such as apparel and bags.
The factory operates in strict accordance with the ISO 13485 medical device quality management system. Leveraging local production advantages, we ensure efficient order delivery to meet export requirements for global clients. Backed by our mature international certification, we satisfy quality and compliance requirements for medical devices and supporting products worldwide, helping customers expand into global markets.