ReWalk® 7 个人外骨骼（50-20-0005）
K号: K241822 · 2025-03-12
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决定日期2025-03-12
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® 7 Personal Exoskeleton (50-20-0005) is the device name listed in this FDA 510(k) record. The listed applicant is Rewalk Robotics Ltd. Dba Lifeward. It received FDA 510(k) clearance on 2025-03-12 under 510(k) number K241822. 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® 7 Personal Exoskeleton (50-20-0005)?
ReWalk® 7 Personal Exoskeleton (50-20-0005) is a medical device that received FDA 510(k) clearance on 2025-03-12. The listed applicant is Rewalk Robotics Ltd. Dba Lifeward. The 510(k) number is K241822.
When did ReWalk® 7 Personal Exoskeleton (50-20-0005) receive FDA 510(k) clearance?
ReWalk® 7 Personal Exoskeleton (50-20-0005) received FDA 510(k) clearance on 2025-03-12, under 510(k) number K241822.
Who is the listed applicant for ReWalk® 7 Personal Exoskeleton (50-20-0005)?
The FDA 510(k) record lists Rewalk Robotics Ltd. Dba Lifeward as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ReWalk® 7 Personal Exoskeleton (50-20-0005)?
The FDA product code for ReWalk® 7 Personal Exoskeleton (50-20-0005) is PHL.
相关临床试验
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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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