SJ Medical
SJ Medical
Explore our medical systems manufactured under cleanroom conditions, complying with major regulatory frameworks globally.
In modern clinical practice, venous thromboembolism (VTE), which manifests primarily as deep vein thrombosis (DVT) and pulmonary embolism (PE), remains a major cause of preventable hospital mortality. Intermittent Pneumatic Compression (IPC) devices represent a proven, non-pharmacological gold standard for DVT prophylaxis. By utilizing pressurized, sequential inflation cycles, these systems actively mimic the muscle pump mechanism of the lower extremities. This increases venous blood velocity, minimizes venous stasis, and enhances systemic fibrinolytic activity, directly addressing Virchow's Triad without the bleeding risks associated with anticoagulants.
For healthcare institutions, rehabilitation centers, and medical device distributors worldwide, sourcing high-durability, clinically compliant Pneumatic Compression Devices is vital. Partnering with a dedicated OEM/ODM manufacturer is essential for developing customized, patient-centric solutions. These partners translate engineering precision into user-friendly control units and ergonomic, multi-chamber garments.
Hangzhou SJ Medical Co., Ltd., established in 2015, is dedicated to the research, development, manufacturing, and commercialization of high-precision medical devices. Our focus spans both vascular intervention and advanced physical therapy systems, striving to provide safe, reliable, and innovative solutions for healthcare providers worldwide.
Over the years, SJ Medical has built a comprehensive medical manufacturing infrastructure. Leveraging our core expertise in vascular interventional technologies—ranging from balloon catheters and micro-guide wires to introducer sheath sets—we have developed a deep understanding of fluid dynamics, pressure management, and biocompatible materials. This expertise has allowed us to expand into high-performance Pneumatic Compression Systems, applying clinical-grade standards to every component.
SJ Medical operates a modern manufacturing facility with a total area of approximately 5,000 square meters. The factory is built in strict accordance with GMP standards and features a high-standard cleanroom environment, including a million-class clean workshop with localized hundred-class clean areas for critical processes (such as micro-valve assembly, electronic sensor calibration, and sealing integrity checks).
Our facility is supported by an experienced technical team, many of whom have been engaged in the medical device industry for decades. Under the leadership of senior biomedical and mechanical engineers, we maintain strict quality control and continuously refine our manufacturing processes to ensure product reliability and consistency.
We provide end-to-end customization services, tailoring hardware, firmware, and garments to meet local regulatory and clinical requirements.
We design custom microprocessor-controlled pumps with options for real-time digital pressure sensors, high-definition LCD touchscreens, customized pressure ranges (20-250 mmHg), and quiet-operation brushless DC motors (<40dB).
Available in 4, 6, or 8-chamber configurations. Built with biocompatible, anti-bacterial TPU-coated nylon fabrics. Options include overlapping chamber designs to prevent pressure dead zones, and heat-sealed seams for durability.
Tailored compression profiles (Sequential, Gradient, Wave, Peristaltic). Custom safety features, including auto-release dump valves during power failure, smart sensor diagnostics, and localized UI languages.
Operating in Hangzhou, China, places SJ Medical at the center of the world's most robust electronics and medical manufacturing cluster. This strategic location offers unique advantages to our global procurement partners:
| OEM Customization Parameter | Standard Specifications | Customization Options |
|---|---|---|
| Pressure Range | 20 mmHg – 200 mmHg | Up to 250 mmHg for athletic recovery |
| Chamber Count | 4 or 6 Chambers (Sequential) | 8 Chambers, overlapping configurations |
| Garment Materials | TPU-Coated Nylon (Anti-bacterial) | PU coated fabrics, custom sizes, custom branding |
| Power Configurations | 220V/50Hz, 110V/60Hz (AC powered) | Rechargeable Lithium-ion battery (up to 6 hours run time) |
| Compliance / Standard | EN ISO 13485:2016, CE (MDR) | FDA 510(k) file support, national registrations |
Entering international medical markets requires strict compliance with complex regulatory frameworks. SJ Medical adheres to global standards to ensure seamless distribution and clinical clearance for our partners:
1. ISO 13485 Quality Management System: Our entire design, testing, and production workflow is audited under ISO 13485:2016, guaranteeing that each manufacturing batch is documented with traceabilty.
2. CE Certification (MDR 2017/745): Our products comply with European Medical Device Regulation requirements, allowing distribution throughout the European Union and associated countries, including Finland, Italy, Spain, France, and the Netherlands.
3. Electrical Compliance & Safety Testing: Our devices undergo verification to meet standard IEC 60601-1 (medical electrical safety) and IEC 60601-1-2 (electromagnetic compatibility) requirements. We support local power plug configurations, custom voltage settings (110V for the USA/Japan, 230V for the EU/UK), and offer localization of user manuals and UI text.
Pneumatic compression devices are engineered to deliver targeted physiological outcomes across different therapeutic contexts.
Designed for post-operative wards, intensive care units (ICUs), and orthopedic recovery departments (total knee and hip replacements). These devices use precise, sequential pressure cycles to maintain venous circulation in immobile patients, reducing the risk of thrombus formation.
For patients managing chronic primary or secondary lymphedema, venous stasis ulcers, and post-mastectomy arm swelling. User-friendly controls, light weight, and soft, biological-grade fabrics make our systems suitable for safe, daily home-use therapy.
Utilized by professional sports teams, physical therapy centers, and athletic training clinics. Higher pressure settings and rapid cycle modes flush out metabolic waste, reduce exercise-induced muscle soreness, and accelerate overall tissue repair.
The global market for pneumatic compression and active rehabilitation technologies is evolving rapidly, driven by clinical research and digital technology. As a progressive manufacturer, we are integrating these key developments into our OEM design pipeline:
Technical and regulatory answers for sourcing managers, biomedical engineers, and medical distributors.
Every pump undergoes calibration utilizing high-precision digital pressure gauges. Our firmware features auto-release safety logic: if pressure exceeds 5 mmHg above the target setting or in the event of a power failure, a mechanical solenoid valve automatically venting all chambers to prevent tissue ischemia. We test for electrical and mechanical safety in compliance with IEC 60601-1 standards.
Our sleeves are constructed from medical-grade thermoplastic polyurethane (TPU)-coated nylon. This fabric is durable, moisture-resistant, and supports disinfection protocols. All skin-contacting materials undergo ISO 10993 biocompatibility testing, ensuring they are free from cytotoxicity, sensitization, and irritation.
Yes. As a custom OEM/ODM manufacturer, we can design specific chamber configurations (such as 4-chamber, 6-chamber, or 8-chamber overlapping sleeves) to meet specific therapeutic protocols. We also offer software customization, translating firmware UI menus and print manuals into multiple languages (including English, Spanish, German, French, Italian, and Turkish).
Standard custom prototyping takes 4–6 weeks depending on requirements. Bulk production orders are completed within 45 days. We provide comprehensive documentation packages, including ISO 13485 test data, CE declaration files, and manufacturing reports, to assist our clients with local medical device registration procedures.
Our background in manufacturing high-precision vascular interventional devices (such as micro-guide wires, sheath introducers, and balloon catheters) gives us deep expertise in micro-fluidics, pressure maintenance, and biocompatible material handling. We apply these same standards of precision to the assembly, calibration, and leak testing of our pneumatic compression systems.
We maintain a comprehensive range of interventional access tools, diagnostic accessories, and patient rehabilitation equipment.
