Power Wheelchair (N6101)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K241686 ↗

FDA Product Code

ITI

FDA applicant

Zhejiang Zhonglei Medical Technology Co. , Ltd.

Device Class

Class II

Regulation

21 CFR Part 890.3860

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Power Wheelchair

  Class I

  CE/MDR

• Superight

  Class I

  CE/MDR GUDID on market

• Power Wheelchair

  Class I

  CE/MDR

• Power wheelchair

  Class II

  FDA 510(k) K242402 Active Cleared 18 Nov 2024

• Power wheelchair

  Class II

  FDA 510(k) K242308 Active Cleared 27 Nov 2024

• Is this power wheelchair designed for single-use or can it be reused after cleaning and maintenance?

  The Power Wheelchair (N6101) is explicitly described as a reusable medical product, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance. Since it is classified as a reusable device under regulatory frameworks like the FDA 510K and MDR, it is not meant for single-use.

• What regulatory pathways has this power wheelchair followed for approval, and what does that mean for its use?

  The Power Wheelchair (N6101) has undergone FDA 510K clearance and complies with the EU Medical Device Regulation (MDR), classified as a Class II device. The FDA pathway involved a traditional 510K submission with a substantially equivalent (SESE) determination by the Physical Medicine (PM) Advisory Committee, ensuring it meets safety and performance standards for powered wheelchairs. This means it is legally authorized for use in both clinical and home settings in the U.S. and EU markets.

• Does this wheelchair come with multiple model or registration numbers, and what does that imply for compatibility or customization?

  Yes, the Power Wheelchair (N6101) is associated with multiple registration numbers (e.g., 9615350, 9615410, etc.), which likely correspond to different model variants or configurations rather than distinct devices. These numbers may reflect variations in features, seating options, or control interfaces, allowing for customization to meet diverse user needs. However, the core design remains consistent under the N6101 classification.

• How should this wheelchair be stored to maintain its functionality and safety over time?

  While the data does not specify exact storage conditions, as a reusable medical device, the Power Wheelchair (N6101) should be stored in a clean, dry, and protected environment to prevent damage from moisture, dust, or physical stress. Since it is intended for long-term use, regular maintenance (e.g., battery checks, mechanical inspections) is critical. The manufacturer’s guidelines—likely provided with the device—should be followed for optimal longevity and safety.

• Are there different sizes or models available for this power wheelchair, and how can I determine which one is right for me?

  The provided data lists multiple registration numbers, which may indicate variations in size, weight capacity, or seating configurations. While exact dimensions or model-specific details aren’t outlined, these differences suggest the wheelchair can be tailored to users with varying mobility needs, body sizes, or clinical requirements. Consulting with a physical medicine specialist or occupational therapist can help select the appropriate model based on individual needs, as the device is regulated under Physical Medicine (PM) standards.