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Electric Wheelchair [Models: JRWD6010/JRWD6012]

by Jerry Medical Instrument (Shanghai) Co., Ltd.

510(k) K192739

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) K192739↗

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 NumberK192739 Date13 Jul 2021ClearedStatusActive
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  • Withdrawn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
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, a mobility aid designed to assist individuals with limited mobility in independent movement. It provides electric propulsion for users who require assistance beyond manual wheelchair capabilities, enabling greater range and ease of use in various environments, including indoor and outdoor settings.

The Electric Wheelchair [Models: JRWD6010/JRWD6012] is supplied as a reusable medical device, intended for clinical use in physical medicine settings. It is classified as Class II under FDA regulations (890.3860) and has received FDA 510(k) clearance and MDR authorization. No specific sterility or MRI safety information is provided, and storage conditions are not detailed in the data. The device is regulated under the Physical Medicine advisory committee and is subject to traditional 510(k) review.

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