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Index News Room Corporate News 资质 | 程天科技多款康复及机器人产品获美国FDA认证

资质 | 程天科技多款康复及机器人产品获美国FDA认证

Release time：2022-09-13

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近日，程天科技多款康复及机器人产品均已完成美国食品药品监督管理局（Food and Drug Administration，简称FDA）医疗器械认证，开启国际市场拓展。通过FDA认可的材料、器械和技术能够在美国等国家进行商业化临床应用，此次程天科技的系列康复机器人产品获批FDA认证，正是企业发展的重要里程碑，也标志着中国自主外骨骼机器人品牌走向世界。







本次通过FDA认证的产品涵盖了下肢步行康复、下肢关节康复、上肢手功能康复、康复助理机器人、智能理疗康复等5大类共9款智能康复设备及机器人。


程天科技完成系列产品的FDA医疗器械注册，即拿到美国市场的“通行证”，为后续产品出口奠定资质基础。随着疫情常态化，全球多国政府都意识到医疗投入的重要性，又面临着更大的财政压力，因此对价格更为敏感，而程天科技的自研自产优势也将愈发凸显。通过此次契机，程天科技将不断尝试将自身设备产品推向国际市场，让国产科技康复更具竞争力，为康复人群提供更优品质的产品与服务。

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