悠行下肢外骨骼步行康复器——首获偏瘫适应症NMPA注册证
Release time:2020-04-28
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此次的成就绝非偶然,程天科技始终秉承着“解决问题、信任彼此、与时俱进”的文化理念,怀揣着让“每一位截瘫、偏瘫患者重新站立起来”的初衷,坚持做有温度的产品,进行着严谨而又创新的研发工作。该产品对构思、设计、研发、工艺、生产等方面精细把控,从每一张图纸、每一个元件、每一个环节、每一个工艺中,反复试验、细心打磨,只为能够呈现一款安全、有效的高科技外骨骼,服务有需要的人群。此产品获得上市许可对当前国产创新型医疗器械行业而言是一个意义非凡的突破——国内首款适用于偏瘫患者进行康复治疗训练的外骨骼智能康复设备,标志着中国首款适用于截瘫、偏瘫患者进行康复训练的外骨骼机器人设备正式进入应用环节,打响 “中国智造”的品牌。

依据《医疗器械分类目录》,下肢外骨骼步行康复器属于步态训练设备。基于“脑的可塑性”原理,中枢神经病变患者穿戴下肢外骨骼步行康复器,通过意图识别,可以进行高效规范的生理步态训练,使患者下肢得到充分的活动,矫正并预防异常步态,实现了代偿行走以及康复训练功能,也为广大患者提供了一种全新的功能代偿和康复训练模式,从而实现站立行走、加速康复进程的新途径。

在注册审批过程中,程天科技以“0缺陷”通过了浙江省药监局的注册和生产许可体系的联合现场审查。此次一次性通过审核,也印证了程天科技在针对外骨骼医疗器械领域的专业与实力。

至此程天科技已完成关于外骨骼机器人销售的全部前置手续,也意味着程天科技的下肢外骨骼步行康复器UGO 210可以正式上市,期待在不久的将来程天科技的外骨骼技术可以应用于更多的领域,给更多的需要帮助的伤友带来新的希望。
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