RoughRider Aurora 手动轮椅
K号: K200715 · 2022-06-24
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决定日期2022-06-24
产品代码IOR
咨询委员会PM
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决定实质等同
器械摘要
RoughRider Aurora Manual Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Roughrider America, LLC. It received FDA 510(k) clearance on 2022-06-24 under 510(k) number K200715. 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 RoughRider Aurora Manual Wheelchair?
RoughRider Aurora Manual Wheelchair is a medical device that received FDA 510(k) clearance on 2022-06-24. The listed applicant is Roughrider America, LLC. The 510(k) number is K200715.
When did RoughRider Aurora Manual Wheelchair receive FDA 510(k) clearance?
RoughRider Aurora Manual Wheelchair received FDA 510(k) clearance on 2022-06-24, under 510(k) number K200715.
Who is the listed applicant for RoughRider Aurora Manual Wheelchair?
The FDA 510(k) record lists Roughrider America, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RoughRider Aurora Manual Wheelchair?
The FDA product code for RoughRider Aurora Manual Wheelchair is IOR.
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。
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
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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