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Electric Wheelchair (W3902)

by Zhejiang Richall Medical Technology Co., Ltd

510(k) K241723

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241723↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK241723 Date5 Sep 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
ITI
FDA applicant
Zhejiang Richall Medical Technology Co., Ltd.
Device Class
Class II
Regulation
21 CFR Part 890.3860
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Electric Wheelchair (W3902) is a powered mobility device designed for individuals requiring assistance with ambulation. Classified as a Class II medical device, it is intended to provide independent movement for users with limited mobility, featuring a lightweight carbon fiber construction for enhanced durability and portability.

This device is supplied as a reusable mobility aid, intended for use in home, clinical, or community settings. It operates via a 24V battery system (24V×10Ah×2) with BLDC motors (24V×200W×2) and includes USB recharge capability. Measuring 96cm × 61cm × 93cm, it has received FDA 510(k) clearance and MDR conformity, with regulatory registration number 890.3860. The device is not MRI-safe and requires proper storage to maintain its two-year shelf life.

Other devices from Zhejiang Richall Medical Technology Co., Ltd

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the key features that make this electric wheelchair suitable for both home and clinical use?

    The Electric Wheelchair (W3902) is designed with a lightweight carbon fiber construction, which enhances durability and makes it highly portable for use in various settings, including homes and clinical environments. It operates on a 24V battery system with two 200W BLDC motors, providing reliable mobility. The wheelchair also includes USB recharge capability, allowing for convenient charging, and its compact dimensions (96cm × 61cm × 93cm) ensure it fits well in different spaces.

  • Is this wheelchair intended for single-use or can it be reused? How should it be maintained?

    The Electric Wheelchair (W3902) is explicitly supplied as a reusable mobility aid, meaning it is not designed for single-use disposal. Proper maintenance is essential to ensure longevity and safe operation. While the device data does not specify cleaning protocols, typical reusable wheelchairs require regular inspection of mechanical components, battery care (e.g., proper charging and storage), and adherence to manufacturer guidelines to preserve functionality and safety.

  • What storage conditions are required to maintain the wheelchair’s two-year shelf life?

    The device’s two-year shelf life depends on proper storage to prevent degradation. While specific storage conditions (e.g., temperature, humidity) aren’t detailed, general best practices for powered mobility devices include keeping the wheelchair in a clean, dry environment away from direct sunlight or extreme temperatures. Batteries should be stored fully charged or partially discharged as per manufacturer instructions to avoid damage, and the wheelchair should be protected from moisture or physical damage.

  • How does the regulatory approval process for this wheelchair differ from other mobility devices?

    This Electric Wheelchair (W3902) has undergone a traditional 510(k) clearance process through the FDA and MDR conformity in the EU, both of which are common pathways for Class II medical devices like powered wheelchairs. The device was reviewed by the Physical Medicine (PM) Advisory Committee, a specialized panel for mobility aids, and classified under product code ITI (Infant/Toddler/Child/Adult Wheelchairs, Powered). This route ensures compliance with safety and performance standards tailored to powered mobility devices, distinguishing it from non-medical or simpler assistive devices.

  • Can this wheelchair be used in an MRI environment, and if not, what alternatives should be considered?

    The Electric Wheelchair (W3902) is not MRI-safe, meaning it should not be used in or near MRI machines due to potential interference or safety risks. If MRI compatibility is required, alternative mobility solutions—such as MRI-safe manual wheelchairs or specialized MRI-compatible powered devices—should be considered. Always consult with radiology staff or healthcare providers to ensure safe transport to and from MRI procedures.