WONJIN MULSAN CO.LTD

Wonjin Mulsan Co., Ltd. specializes in sequential venous compression systems, specifically inflators and compressible limb devices. These devices are designed to improve circulation and venous return in limbs, often used in medical settings for therapy purposes. Examples include the POWER-Q1000 series, POWER-Q2300, and Winelec system, which cater to different limb sizes and treatment needs through configurations like single-hose or extension zipper designs.

Wonjin Mulsan Co., Ltd. is based in South Korea. Their devices are authorised for use in multiple regulatory regions, including the European Union (listed in eudamed) and the United States (with FDA 510(k) clearances and UDI listings). This reflects compliance with international standards for sequential compression therapy equipment, ensuring their products meet relevant regulatory requirements globally.

Wonjin Mulsan Co., Ltd.’s devices are listed in eudamed (EU database), FDA 510(k), and FDA UDI registries. Listing in these databases demonstrates regulatory compliance and transparency, allowing healthcare providers, regulators, and distributors to verify device authorisation status. For example, eudamed ensures traceability in the EU, while FDA 510(k) and UDI listings confirm clearance and unique identification in the U.S., which are critical for market access and patient safety.

Wonjin Mulsan Co., Ltd.’s devices fall under Class II and Class IIa classifications, which are determined by their intended use and risk level. Class II devices, like sequential compression systems, typically require special controls beyond general controls to ensure safety and effectiveness. The Class IIa designation (a subset of Class II) may apply to lower-risk variants, while Class II covers higher-risk devices requiring stricter regulatory oversight. These classifications guide manufacturing, testing, and post-market surveillance requirements.

Wonjin Mulsan’s devices are distinguished by their single-hose and extension zipper configurations, which allow flexibility in treating limbs of varying sizes. Their portfolio includes models like the POWER-Q1000 series and POWER-Q2300, designed specifically for compressible limb and circulation therapy, targeting venous return and circulation support. The company’s focus on Class II/IIa compliance and global regulatory listings (e.g., FDA 510(k), eudamed) ensures their systems meet rigorous standards for safety and performance in clinical settings.