Rowheels Revolution 1.0
K号: K190699 · 2019-05-09
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决定日期2019-05-09
产品代码IOR
咨询委员会PM
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器械摘要
Rowheels Revolution 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Rowheels, Inc.. It received FDA 510(k) clearance on 2019-05-09 under 510(k) number K190699. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Rowheels Revolution 1.0?
Rowheels Revolution 1.0 is a medical device that received FDA 510(k) clearance on 2019-05-09. The listed applicant is Rowheels, Inc.. The 510(k) number is K190699.
When did Rowheels Revolution 1.0 receive FDA 510(k) clearance?
Rowheels Revolution 1.0 received FDA 510(k) clearance on 2019-05-09, under 510(k) number K190699.
Who is the listed applicant for Rowheels Revolution 1.0?
The FDA 510(k) record lists Rowheels, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rowheels Revolution 1.0?
The FDA product code for Rowheels Revolution 1.0 is IOR.
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相关器械（代码：IOR）
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。
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官方来源
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