ReWalk P6.0
K号: K200032 · 2020-05-26
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决定日期2020-05-26
产品代码PHL
咨询委员会PM
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决定实质等同
器械摘要
ReWalk P6.0 is the device name listed in this FDA 510(k) record. The listed applicant is Re Walk Robotics , Ltd.. It received FDA 510(k) clearance on 2020-05-26 under 510(k) number K200032. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ReWalk P6.0?
ReWalk P6.0 is a medical device that received FDA 510(k) clearance on 2020-05-26. The listed applicant is Re Walk Robotics , Ltd.. The 510(k) number is K200032.
When did ReWalk P6.0 receive FDA 510(k) clearance?
ReWalk P6.0 received FDA 510(k) clearance on 2020-05-26, under 510(k) number K200032.
Who is the listed applicant for ReWalk P6.0?
The FDA 510(k) record lists Re Walk Robotics , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ReWalk P6.0?
The FDA product code for ReWalk P6.0 is PHL.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Re Walk Robotics , Ltd.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：PHL）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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