Bowhead ERA轮椅
K号: K243111 · 2025-01-10
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决定日期2025-01-10
产品代码IOR
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器械摘要
Bowhead ERA Wheelchairs is the device name listed in this FDA 510(k) record. The listed applicant is Bowhead Design Corp.. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K243111. 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 Bowhead ERA Wheelchairs?
Bowhead ERA Wheelchairs is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Bowhead Design Corp.. The 510(k) number is K243111.
When did Bowhead ERA Wheelchairs receive FDA 510(k) clearance?
Bowhead ERA Wheelchairs received FDA 510(k) clearance on 2025-01-10, under 510(k) number K243111.
Who is the listed applicant for Bowhead ERA Wheelchairs?
The FDA 510(k) record lists Bowhead Design Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bowhead ERA Wheelchairs?
The FDA product code for Bowhead ERA Wheelchairs is IOR.
相关临床试验
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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
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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