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Q6 Edge EM Powered Wheelchair

by Pride Mobility Product Corporation

510(k) K143383

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

7 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K143383↗

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 NumberK143383 Date23 Jul 2015ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

7 recalls · 7 ongoing · FDA

  • 7 recalls, same reason

    • Ongoing Z-2849-2026 FDA Class II initiated 25 Jun 2026
    • Ongoing Z-2852-2026 FDA Class II initiated 25 Jun 2026
    • Ongoing Z-2843-2026 FDA Class II initiated 25 Jun 2026
    • Ongoing Z-2851-2026 FDA Class II initiated 25 Jun 2026
    • Ongoing Z-2848-2026 FDA Class II initiated 25 Jun 2026
    • Ongoing Z-2841-2026 FDA Class II initiated 25 Jun 2026
    • Ongoing Z-2850-2026 FDA Class II initiated 25 Jun 2026

    If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

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  • Withdrawn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)

Full name
Q6 Edge EM
510(k) Number
FDA Product Code
ITI
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 Q6 Edge EM is a powered wheelchair classified as a Wheelchair, Powered, designed for mobility assistance. It features a mid-wheel drive configuration with six wheels on the ground, enhancing stability and performance for active users.

This device is supplied as a reusable medical mobility aid, intended for clinical and home use. It is regulated under FDA 510(k) clearance (K143383) and the EU Medical Device Regulation (MDR), with a classification of Class II. No specific sterility or MRI safety information is provided in the data.

Other devices from Pride Mobility Product Corporration

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 the Q6 Edge EM designed for, and how is it typically supplied?

    The Q6 Edge EM is a reusable powered wheelchair designed for both clinical (e.g., hospital or rehabilitation settings) and home use. Since it is classified as a reusable medical mobility aid, it is not intended for single-use and is meant to be maintained and cleaned for long-term use by authorized personnel.

  • Does the Q6 Edge EM come in different sizes or models, and how would I determine the right fit for a user?

    The Q6 Edge EM is available in multiple configurations, as indicated by the extensive list of FEI numbers (e.g., 3004730072, 3014522447, etc.), which likely correspond to different wheelbase lengths, seat widths, or other customizable features. To determine the right fit, consult a mobility specialist or physical therapist who can assess the user’s size, mobility needs, and environment to select the appropriate model.

  • Is the Q6 Edge EM sterile when it arrives, and if not, what are the recommended cleaning or maintenance procedures?

    The Q6 Edge EM is not described as a sterile device, so it is not expected to arrive pre-sterilized. Since it is reusable, it should be cleaned and maintained according to manufacturer guidelines, typically involving wiping down surfaces with appropriate disinfectants and following Pride Mobility’s recommended care protocols to ensure hygiene and longevity.

  • What regulatory pathways does the Q6 Edge EM follow, and how does this affect its availability in different markets?

    The Q6 Edge EM has undergone FDA 510(k) clearance (K143383) and is classified under the EU Medical Device Regulation (MDR) as a Class II device. This means it is legally marketed in the U.S. under FDA regulations and in the EU under MDR compliance, ensuring it meets safety and performance standards for both regions. Availability may vary by country based on local regulatory requirements.

  • How does the mid-wheel drive configuration of the Q6 Edge EM benefit users, and is this feature standard across all models?

    The mid-wheel drive configuration of the Q6 Edge EM enhances stability and maneuverability, making it particularly suitable for active users who require precise control and balance. While the mid-wheel drive is a defining feature of this model, the specific variations (e.g., wheelbase, seat dimensions) are likely what differentiate the individual FEI-numbered configurations listed, so not all models may share identical specifications beyond the core drive system.