Attainment of CE Mark Approval for Hand of Hope System

2012-10-19

The Rehab-Robotics Company Ltd. (“the Company”) is pleased to announce that it has received the CE Mark approval for its Hand of Hope system (“HOH”).

The Certification Body of MEDCERT declares that the company has implemented a quality assurance system for design, manufacture and final inspection of the HOH system in accordance with Medical Devices Directive (“MDD”) Annex II.

At the same time, HOH system has also achieved EN ISO 13485:2003/AC:2009 (“ISO13485”) Medical Devices Certification ‐‐ an internationally recognized quality standard designed to ensure that medical device manufacturers have the necessary comprehensive quality system in place to safely design, develop, manufacture and distribute medical devices.

The HOH system is intended to help the stroke survivors to regain the hand function by active rehabilitation training. The Hand of Hope Robotics System is a commercial product developed by our company. It consists of hand brace, advanced robotics processing, surface EMG sensors, control case and exercise software. Through active training, it employs feedback-based closed loop system to facilitate muscle re-education of stroke patient. This system won one Gold and three Silver Medals at 62nd International Trade Fair "Ideas - Inventions - New Products" of Nuremberg, Germany, 2011 and the most notable Grand Prix Award in 40th International Exhibition of Inventions, Geneva, 2012.

The Company is also pleased to announce that our HOH system will be exhibiting at MEDICA 2012, to be held in Germany from 14 to 17 November 2012.

"Receiving ISO 13485 certification and CE mark approval confirms that our quality system meets the high standards required of medical device companies and we are pleased to have achieved this important milestone. It marks the beginning of successful transformation and foothold into the rehabilitation industry,” commented Michael Tsui, CEO of the Company, upon the elated receipt of the CE mark approval.

 

復康機器人技術有限公司特此宣佈希望之手康復訓練系統（“希望之手”）已獲頒CE 標簽認證。歐盟授權認證機構MEDCERT證實本公司已遵循歐盟醫療器材（MDD）指令之附錄II，針對希望之手的設計、生産及最後審查設立了一套完整的品質鑑定系統。

與此同時，本公司的希望之手就已取得EN ISO 13485:2003/AC:2009 (簡稱“ISO13485”) - 為確保醫療器材製造商具備完善的質量管理體系以設計、開發、生產及銷售醫療器材的國際品質標準認證。

希望之手用於幫助中風患者通過主動康復訓練重獲手部功能。希望之手是本公司的自主研發的商業產品。該系統包含符合人工學設計的機械手，肌電信號感應器，中央控制盒以及特製的訓練軟件。當患者主動控制手指張合時，相應的肌肉會增大肌電信號，該系統通過檢測相應的肌肉的肌電信號，協助患者張合手指，通過這樣的肌肉-神經再學習反饋原理，使得患者康復手部功能。

希望之手獲得多項國際榮譽，其中包括2011年德國舉行的第六十二屆「國際創意、發明及新產品展」中奪取金獎；2012年第四十屆日內瓦國際發明展高榮譽大獎-格蘭披治大獎(Grand Prix Du Salon International Des Invention De Genève)。

同時，本公司也欣然宣告希望之手即將參與11 月14 至17 日於德國舉辦的MEDICA 2012。

“我們很高興復康機器人技術有限公司能達至這個重要的里程碑，因爲能獲發ISO13485 認證書和CE 標簽認證證實了我們的品管體系已符合醫療器材公司所需的高規格。這是復康機器人技術有限公司在醫療產業的大力發展的開始。” 公司執行長徐錦輝先生雀躍地說。