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Electric Wheelchair (N3901)

by Zhejiang Richall Medical Technology Co., Ltd

510(k) K241721

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) K241721↗

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 NumberK241721 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  • Withdrawn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.

This device is a Powered Wheelchair (Device Type: ITI), designed to provide mobility assistance for individuals with limited ambulatory function. It is motorised, allowing users to propel themselves through electric power while maintaining manual control over direction and speed, enhancing independence and accessibility in indoor and outdoor environments.

The Electric Wheelchair (N3901) is intended for clinical use in settings such as home care, rehabilitation centres, and healthcare facilities. It is classified as a Class II medical device under FDA regulations and has received FDA 510K clearance and MDR authorisation. Supplied as a reusable device, it requires proper maintenance and cleaning protocols to ensure safety and functionality. No specific MRI safety information is provided, and its regulatory status is confirmed through the listed authorisations.

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 types of environments is this electric wheelchair designed for use in, and how does it enhance user independence?

    The Electric Wheelchair (N3901) is specifically designed for indoor and outdoor environments, making it suitable for use in home care settings, rehabilitation centers, and healthcare facilities. It provides motorized propulsion while allowing users to manually control direction and speed, which significantly enhances independence by enabling mobility for individuals with limited ambulatory function.

  • Is this wheelchair intended for single-use or reusable applications, and what maintenance is required?

    The Electric Wheelchair (N3901) is supplied as a reusable device, meaning it is not meant for single-use. Proper maintenance and cleaning protocols are essential to ensure its safety and functionality over time. The manufacturer emphasizes adherence to these protocols to sustain performance.

  • What regulatory pathways has this device undergone, and what does that mean for its use in clinical settings?

    The Electric Wheelchair (N3901) has received FDA 510K clearance and MDR authorization, confirming its compliance with regulatory standards. This classification as a Class II medical device under FDA regulations ensures it meets established safety and performance criteria, making it suitable for clinical use in settings like home care, rehabilitation, and healthcare facilities.

  • Are there any specific safety considerations for this wheelchair, such as MRI compatibility or special handling?

    The manufacturer does not provide MRI safety information for this device, meaning it should not be used in MRI environments unless explicitly verified as safe. Since it is reusable, proper maintenance and cleaning are critical to ensure functionality and safety. No additional handling restrictions are mentioned beyond standard care for powered mobility devices.