Skip to content

Wheelchair

by Zhenjiang Assure Medical Equipment Co., Ltd

Ref YJ-037, AL-001Model YJ-037/AL-001/AL-002/YJ-059/S2/S5/AL-BL08/AL-005510(k) K231320

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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231320↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Overview

This wheelchair is a highly advanced medical device designed for individuals with mobility issues. Equipped with cutting-edge technology, it provides safe and efficient transportation, improving the quality of life for those who use it.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697423110ASSUREWCBX Basic UDI-DI Date25 Dec 2024RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK231320 Date5 Jun 2023ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / Reference
YJ-037/AL-001/AL-002/YJ-059/S2/S5/AL-BL08/AL-005, YJ-037, AL-001
Primary DI / UDI-DI
06974231101338, 06974231101420
Basic UDI-DI
697423110ASSUREWCBX
510(k) Number
FDA Product Code
IOR
EMDN Code
Y122103 Push wheelchairs
Device Class
Class I
Regulation
21 CFR Part 890.3850
EU market of registration
Germany
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Manufacturer details

EUDAMED SRN
CN-MF-000001076
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Zhenjiang Assure Medical Equipment Co., Ltd

See all devices from Zhenjiang Assure Medical Equipment Co., Ltd →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No