速驰电动轮椅
K号: K231315 · 2024-01-12
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决定日期2024-01-12
产品代码ITI
咨询委员会PM
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决定实质等同
器械摘要
Velox Power Chair is the device name listed in this FDA 510(k) record. The listed applicant is Velox Manufacturing, Inc.. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K231315. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Velox Power Chair?
Velox Power Chair is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Velox Manufacturing, Inc.. The 510(k) number is K231315.
When did Velox Power Chair receive FDA 510(k) clearance?
Velox Power Chair received FDA 510(k) clearance on 2024-01-12, under 510(k) number K231315.
Who is the listed applicant for Velox Power Chair?
The FDA 510(k) record lists Velox Manufacturing, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Velox Power Chair?
The FDA product code for Velox Power Chair is ITI.
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：ITI）
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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