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KMID : 1142220140090010051
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Regulatory Research on Food, Drug & Cosmetic
2014 Volume.9 No. 1 p.51 ~ p.61
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A Study on Development of a Guideline for Safety and Performance Evaluation of Wheelchair Integrated Lower-Limb Rehabilitation System
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Lee Jong-Chul
Kim Hyeog-Ju
Cho Eun-Jeong
Kim San
Lee Ji-Yoon
Jeong Ho-Bae
Kang Shin-Jung
Lee Jae-Won
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Abstract
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Domestic and overseas consumers requiring rehabilitation devices to improve quality of life such as those disabled or suffering from paralyzed limbs due to spinal injuries and strokes have increased in the past years as the use and benefits of these devices have also increased. In some developed countries, diverse devices supporting movement and rehabilitation of persons with severe disabilities have been developed and commercialized, but not a particular case has been promoted in Korea. No relevant evaluation technology has been prepared as well. Therefore, difficulties in future permit examination is foreseen. The permit examination needs to be urgently supported by developing Evaluation Guidelines for Ensuring Performance and Safety of Lower Limb Rehabilitation System Coupled with Wheelchair (draft) in order to help the disabled suffering from spinal cord injury, stroke, and other severe disabilities who cannot exercise lower limb and conduct rehabilitation by themselves. This study is to prepare the performance and safety evaluation items for the motorized wheelchair with added lower limb exercise functions in line with the international standards and to review the relevant feasibility of fabricating Guidelines (draft) for supporting the examination process and for promoting manufacturing of medical device satisfying the international standards.
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KEYWORD
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Electrical wheelchairs, Lower-limb exercise, Safety and performance test methods
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