Top Page | English | 简体中文 | 繁體中文 | 한국어 | 日本語
Thursday, 18 January 2018, 15:25 HKT/SGT
Share:
    

Source: Honda
Honda Walking Assist Obtains Medical Device Approval in the EU

TOKYO, Jan 18, 2018 - (JCN Newswire) - Honda Motor Co., Ltd. today announced that the Honda Walking Assist Device(1), an assistive device for use in the training and rehabilitation of walking, has obtained the Medical Devices Directive (Council Directive 93/42/EEC) certification, which enables Honda to affix the CE marking and commercialize the device within the European Union (EU) countries.


Honda Walking Assist Device


Honda Walking Assist Device in use


Conformity with EU standards (EU Directives) and affixing the CE marking on the product, a certification mark that indicates conformity with EU standards, are mandatory in order to distribute and sell the product in EU countries. Various products including machinery, electrical equipment designed for use within certain voltage limits (low voltage) and toys are subject to EU directives, and the Medical Devices Directive (MDD) sets harmonized standards for medical devices, and conformity with the Directive certifies the manufacturer to affix the CE marking on a product.

The Honda Walking Assist Device obtained an MDD approval and CE marking as a medical device which comply with standards mandated by the MDD, enabling Honda to apply the CE marking on the Walking Assist Device.

Moreover, the Honda Walking Assist Device became the first case of MDD approval that was obtained through a cooperative approach between the Japan Quality Assurance Organization (JQA), a Japan-based third-party ISO certification organization, and TUV Nord Cert GmbH(2), a German-based third-party certification organization, which leveraged assessment and certification based on the ISO 13482 certification(3) that the Honda Walking Assist Device had already obtained.

With this MDD approval, Honda today (on January 18, 2018) received the MDD certificate from TUV Nord Cert GmbH in the presence of the JQA.

While continuing its research and development efforts since 1999, Honda began lease sales of the Honda Walking Assist Device in November 2015 to organizations and businesses in Japan as an assistive device for use in the training of walking. As of today, the Honda Walking Assist Device is being used at approximately 250 facilities throughout Japan to assist training of walking and measure walking capability.

http://www.acnnewswire.com/topimg/Low_HondaHWADevice.jpg
Honda Walking Assist Device

http://www.acnnewswire.com/topimg/Low_HondaHWADeviceUse.jpg
Honda Walking Assist Device in use

(1) The Honda Walking Assist Device is a device designed for the purpose of assisting the person who wears it in walking rehabilitation. In Japan, it is not approved as medical equipment designed for the purpose of diagnosing, treating or preventing a disorder of the user.
(2) TUV Nord Cert GmbH is an international third-party certification organization headquartered in Hannover, Germany. TUV Nord Cert GmbH operates in approximately 70 countries and regions around the world.
(3) The International Organization for Standardization (ISO) issued ISO 13482 in 2014 as the only international safety standard for personal care robots (living-support robot) in the world. The Honda Walking Assist Device obtained the ISO 13482 certificate in October 2015.


About Honda

Honda Motor Co., Ltd. (TSE:7267 / NYSE:HMC / LSE:HNDA) is one of the leading manufacturers of automobiles and power products and the largest manufacture of motorcycles in the world. Honda has always sought to provide genuine satisfaction to people worldwide. The result is more than 120 manufacturing facilities in 30 countries worldwide, producing a wide range of products, including motorcycles, ATVs, generators, marine engines, lawn and garden equipment and automobiles that bring the company into contact with over 19 million customers annually.

For more information, please visit http://world.honda.com.

Contact:
Honda
Media Inquiries
[email protected]
+81-3-5412-1512


Jan 18, 2018 15:25 HKT/SGT
Source: Honda

Topic: Press release summary
Sectors: Automotive
http://www.acnnewswire.com
From the Asia Corporate News Network


Copyright © 2020 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.


Honda Links

http://www.honda.com

https://plus.google.com/110355594819754396833

https://www.facebook.com/HondaJP

https://twitter.com/HondaJP

https://www.youtube.com/user/HondaJPPR

https://ph.linkedin.com/company/honda-motor-co-ltd-

Honda
Oct 1, 2020 08:50 HKT/SGT
Honda to Mark 50th Anniversary of its Driving Safety Promotion Center and the Pursuit of Human-focused Safety Initiatives
Sept 30, 2020 09:26 HKT/SGT
Honda Sets Monthly Records for Automobile Production in China
Sept 28, 2020 09:22 HKT/SGT
Honda Exhibits World Premiere of "Honda SUV e:concept" at the 2020 Beijing International Automotive Exhibition (Auto China 2020)
Sept 15, 2020 11:23 HKT/SGT
Overview of Honda and Acura Exhibits for the 2020 Beijing International Automotive Exhibition (Auto China 2020)
Sept 9, 2020 11:21 HKT/SGT
HondaJet Elite Delivered to Red Bull Formula 1 Racing Team Scuderia AlphaTauri
Sept 4, 2020 08:46 HKT/SGT
Honda and General Motors Sign MoU Toward Establishing a Strategic Alliance in North America
Aug 28, 2020 16:17 HKT/SGT
Honda Sets Monthly Records for Automobile Production Overseas and in China
Aug 5, 2020 17:45 HKT/SGT
Honda's Consolidated Financial Summary for the Fiscal Q1 Ended June 30, 2020 and Forecasts for the FY Ending March 31, 2021
July 30, 2020 14:26 HKT/SGT
Honda Sets Monthly Records for Automobile Production in China
July 13, 2020 11:48 HKT/SGT
CATL and Honda Sign Agreement to Form Comprehensive Strategic Alliance on Batteries for New Energy Vehicles
More news >>
 News Alerts
Copyright © 2020 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Privacy Policy | Terms of Use | RSS
US: +1 800 291 0906 | Beijing: +86 400 879 3881 | Hong Kong: +852 2217 2912 | Singapore: +65 6304 8926 | Tokyo: +81 3 6859 8575

Connect With us: