EvoWalk 1.0 系统
K号: K230997 · 2023-12-28
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决定日期2023-12-28
产品代码GZI
咨询委员会NE
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器械摘要
EvoWalk 1.0 System is the device name listed in this FDA 510(k) record. The listed applicant is Evolution Devices, Inc.. It received FDA 510(k) clearance on 2023-12-28 under 510(k) number K230997. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EvoWalk 1.0 System?
EvoWalk 1.0 System is a medical device that received FDA 510(k) clearance on 2023-12-28. The listed applicant is Evolution Devices, Inc.. The 510(k) number is K230997.
When did EvoWalk 1.0 System receive FDA 510(k) clearance?
EvoWalk 1.0 System received FDA 510(k) clearance on 2023-12-28, under 510(k) number K230997.
Who is the listed applicant for EvoWalk 1.0 System?
The FDA 510(k) record lists Evolution Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EvoWalk 1.0 System?
The FDA product code for EvoWalk 1.0 System is GZI.
相关临床试验
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相关器械（代码：GZI）
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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