电动轮椅（型号P2）
K号: K252428 · 2025-09-18
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决定日期2025-09-18
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
Electric Wheelchair (Model P2) is the device name listed in this FDA 510(k) record. The listed applicant is Superpi Robot Co., Ltd.. It received FDA 510(k) clearance on 2025-09-18 under 510(k) number K252428. 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 Electric Wheelchair (Model P2)?
Electric Wheelchair (Model P2) is a medical device that received FDA 510(k) clearance on 2025-09-18. The listed applicant is Superpi Robot Co., Ltd.. The 510(k) number is K252428.
When did Electric Wheelchair (Model P2) receive FDA 510(k) clearance?
Electric Wheelchair (Model P2) received FDA 510(k) clearance on 2025-09-18, under 510(k) number K252428.
Who is the listed applicant for Electric Wheelchair (Model P2)?
The FDA 510(k) record lists Superpi Robot Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Electric Wheelchair (Model P2)?
The FDA product code for Electric Wheelchair (Model P2) 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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