TAIZHOU, CHINA — Zhejiang Wei Ling New Energy Technology Co., Ltd., a leading innovator in personal mobility solutions, is proud to announce that its latest mobility scooters, models CL-Q3 and CL-Q4, have officially received FDA Class II Medical Device Clearance (K253631).
This milestone reflects the company’s commitment to meeting the highest international standards for safety, reliability, and performance in the medical device industry. Unlike standard recreational scooters, FDA-cleared devices undergo rigorous testing to ensure they are safe for individuals with mobility impairments.
Exceeding Global Safety Standards
The CL-Q3 and CL-Q4 models were evaluated for structural integrity, battery safety, and electromagnetic compatibility. By securing this clearance, Zhejiang Wei Ling ensures that healthcare providers and end-users can trust the durability and medical-grade engineering of these products.
The CL-Q3 and CL-Q4 models were evaluated for structural integrity, battery safety, and electromagnetic compatibility. By securing this clearance, Zhejiang Wei Ling ensures that healthcare providers and end-users can trust the durability and medical-grade engineering of these products.
Key Benefits of the FDA-Cleared CL-Series:
- Medical-Grade Assurance: Specifically designed to assist those with mobility challenges under strict FDA Class II guidelines.
- Safety Verified: Proven stability and braking performance for daily use.
- Insurance Eligibility: As a cleared medical device, these models may qualify for reimbursement through various medical insurance providers when prescribed by a physician.
“Our goal has always been to empower individuals through advanced technology,” said a spokesperson for Zhejiang Wei Ling. “Receiving FDA clearance for the CL-Q3 and CL-Q4 validates our hard work and allows us to better serve the North American market with products that are both innovative and safe.”
Verification Details:
Customers and partners can verify this listing on the official FDA Establishment Registration & Device Listing database using the following details:
Customers and partners can verify this listing on the official FDA Establishment Registration & Device Listing database using the following details:
- Establishment Name: ZHEJIANG WEI LING NEW ENERGY TECHNOLOGY CO., LTD.
- Listing Number: D593198 (K253631)
- Product Code: INI (Mobility Scooter)
- Inquiry Website: FDA AccessData Search
About Zhejiang Wei Ling New Energy Technology Co., Ltd.
Located at No.12 Jinnan Road, Sanmen County, Taizhou City, Zhejiang, China, the company specializes in the research, development, and manufacturing of high-quality electric mobility solutions for the global market.
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