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From concept to mass production, we provide a complete and efficient customization process to bring your healthcare products to market.
Gain a thorough understanding of your specific needs, target market, product positioning, and functional requirements to lay a precise foundation for subsequent solutions.
Provide product concepts, technical solutions, preliminary specifications, estimated costs, and project timelines.
Complete structural, electronic, firmware, software, appearance, and packaging design based on the approved solution.
Develop prototypes and conduct performance, safety, usability, and reliability testing for customer approval.
Support testing and documentation for FDA, Medical CE, ISO 13485, MDSAP, and other target-market requirements.
Complete pilot production, quality inspection, mass production, packaging, and timely global delivery.
With over 20+ years of expertise, we deliver safe and high-quality home healthcare solutions to users worldwide.
Certified with FDA 510(k), Medical CE, ISO 13485 and MDSAP for full compliance with global regulatory standards.
Professional team of over 30+ engineers dedicated to continuous innovation and technology advancement.
5,000㎡ modern factory with four automated lines and monthly capacity exceeding 150,000 units.
Full traceability from requirement analysis to delivery, guaranteeing safety and consistency in every device.
Hong Qiangxing (Shenzhen) Electronics Limited, established in 2003, is a leading developer and manufacturer of home healthcare devices in China. Our core brand Sunmas is dedicated to delivering professional, safe and convenient home health solutions worldwide.
Solution Proposal
Deliver product concepts, technical pathways, and preliminary specifications based on your needs.
Rigorous Quality Control
Full traceability from requirement analysis to delivery, guaranteeing safety and consistency in every device.
Each milestone marks a step forward in our pursuit of innovation and excellence.
Obtained Medical CE certification, further strengthening compliance in the European market. This certification significantly improved market access for medical and wellness applications in Europe and enhanced the brand’s professional recognition and competitiveness in global markets.
SUNMAS brand was officially established, initially focusing on the R&D and production of TENS therapeutic massage slippers. With stable product quality and a clear market positioning, the brand quickly gained strong recognition in Indonesia and gradually became one of the well-known local health and wellness brands, laying a solid foundation for future international expansion.
The company entered the U.S. market, marking a key step in its global expansion strategy. The TENS model SM9128 became a representative classic product in the industry due to its stable performance and positive user feedback. SUNMAS gradually established a stable customer base in the U.S. and became an important player in the electrotherapy sector.
The company successfully obtained its first FDA 510(k) clearance, officially entering the regulated medical device system. This milestone significantly enhanced product compliance in international markets and enabled access to North America and other high-standard regulatory regions.
Passed the ISO 13485 medical device quality management system certification, establishing a fully compliant international quality management system. At the same time, the DOMAS brand was officially registered, further improving the company’s multi-brand strategy and global product portfolio.
To further enhance R&D and manufacturing capabilities, the company established a R&D center in Chongqing and invested several million RMB in product development and production system upgrades. The Roblink R&D center was also established, forming a professional R&D team of over 30+ members. The factory was expanded to a 5,000 m² modern production facility, with the workforce increasing to 200 employees and equipped with four automated production lines, achieving stronger integration between R&D and large-scale manufacturing.
Successfully passed the MDSAP (Medical Device Single Audit Program), enabling unified regulatory access across major medical device markets including the United States, Canada, Australia, Japan, and Brazil. This milestone further strengthened the company’s global regulatory compliance capabilities and international competitiveness in the medical device industry.
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