Zhongshan Sulenz Intelligent Technology Obtains FDA 510(k) Clearance for Its Electric Wheelchair S500-6

Zhongshan, China – June 15, 2026 – Zhongshan Sulenz Intelligent Technology Co., Ltd. is pleased to announce that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Electric Wheelchair model S500-6 (K260335).

This important regulatory milestone confirms that the S500-6 electric wheelchair is substantially equivalent to legally marketed predicate devices and meets the FDA’s safety and effectiveness requirements for Class II powered wheelchairs. The clearance authorizes Sulenz to market and sell the S500-6 in the United States.

The S500-6 is a high-quality, user-friendly electric wheelchair designed to provide reliable mobility and enhanced comfort for individuals with limited mobility. With its robust construction, ergonomic design, and practical features, the product aims to improve independence and quality of life for users and caregivers.

“We are very proud to receive FDA 510(k) clearance for the S500-6,” said Mr. Steven, the General Manager of Zhongshan Sulenz Intelligent Technology Co., Ltd. “This clearance validates our commitment to product quality, safety, and innovation. It represents a key milestone in our global expansion and demonstrates our capability to meet the stringent regulatory standards of the U.S. market.”

With this FDA clearance, Sulenz will accelerate its entry into the U.S. market, offering American users and healthcare providers a reliable and competitively priced powered mobility solution.

The company remains committed to continuous innovation, strict quality control, and full compliance with international regulatory requirements to deliver advanced mobility solutions worldwide.

About Zhongshan Sulenz Intelligent Technology Co., Ltd. Zhongshan Sulenz Intelligent Technology Co., Ltd. is a professional manufacturer specializing in the research, development, and production of high-quality electric wheelchairs and mobility aids. Focused on innovation, safety, and user-centric design, Sulenz is dedicated to improving the lives of people with mobility challenges through intelligent and reliable mobility solutions.