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Electric Wheelchair - Electric Wheelchair (HBLD3-E)

by Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd

510(k) K240913

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) K240913↗

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 NumberK240913 Date31 May 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  • Withdrawn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
Models / Variants
Electric Wheelchair (HBLD3-E)
FDA applicant
Shanghai Hubang Intelligent Rehabilitation Equipment 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 (HBLD3-B and HBLD3-E) is a motor-driven, powered wheelchair designed for indoor and outdoor mobility. It is classified as a Class 2 Physical Medicine device under the FDA nomenclature, intended for disabled or elderly users requiring assisted transportation.

These devices are supplied as reusable mobility aids, featuring components such as a frame, front/drive wheels, controller, motors, armrests, backrest, seat cushion, seatbelt, pedals, and a Li-ion battery pack. They are regulated under FDA 510(k) clearance (K240913) and MDR, with product code ITI, and are intended for traditional use in physical medicine settings. No specific sterility or MRI safety information is provided.

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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.

  • Are these electric wheelchairs intended for single-use or can they be reused over time?

    The Electric Wheelchair (HBLD3-B and HBLD3-E) is explicitly designed as a reusable mobility aid. The device description lists components like the frame, motors, armrests, and battery pack, all of which are meant for long-term use in physical medicine settings. There is no indication of single-use requirements or disposability.

  • What types of environments are these electric wheelchairs suitable for, and how does that affect their use?

    These wheelchairs are engineered for both indoor and outdoor mobility, making them versatile for a range of settings like homes, clinics, and public spaces. Since they are reusable and intended for traditional physical medicine use, they are not classified as sterile medical devices, so they should not be used in sterile environments (e.g., operating rooms) unless additional cleaning protocols are implemented.

  • How do I determine which model (HBLD3-B or HBLD3-E) is right for my needs, and are there size variations?

    The provided data does not specify distinct size variations or model-specific features between the HBLD3-B and HBLD3-E. Both are classified under the same product code (ITI) and regulatory pathway, so differences would likely be manufacturer-defined (e.g., weight capacity, battery life, or design preferences). For precise sizing, consult the manufacturer’s technical specifications or a healthcare professional to ensure compatibility with the user’s needs.

  • What storage requirements should I follow for these electric wheelchairs to maintain their functionality?

    The data does not provide explicit storage guidelines, but as a general recommendation for reusable electric wheelchairs, they should be stored in a dry, temperature-controlled environment to protect components like the Li-ion battery pack from damage. Avoid exposure to extreme heat, cold, or direct sunlight. Regular maintenance (e.g., cleaning, checking battery charge) is advised to ensure safe and reliable operation.

  • What regulatory pathway was followed for these electric wheelchairs, and how does that affect their use?

    The Electric Wheelchair (HBLD3-B and HBLD3-E) was cleared through the FDA 510(k) pathway (K240913) under the classification of a Class 2 Physical Medicine device, with a determination of *Substantially Equivalent* (SESE). It is also compliant with the EU MDR (Medical Device Regulation). This means the device meets established safety and performance standards for powered wheelchairs in physical medicine settings, but it is not intended for use in sterile procedures or MRI environments unless explicitly stated otherwise.