轮椅（N817）
K号: K251565 · 2025-10-06
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决定日期2025-10-06
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
Wheelchair (N817) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Topwe Tools Manufacturing Co.,Ltd. It received FDA 510(k) clearance on 2025-10-06 under 510(k) number K251565. 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 Wheelchair (N817)?
Wheelchair (N817) is a medical device that received FDA 510(k) clearance on 2025-10-06. The listed applicant is Zhejiang Topwe Tools Manufacturing Co.,Ltd. The 510(k) number is K251565.
When did Wheelchair (N817) receive FDA 510(k) clearance?
Wheelchair (N817) received FDA 510(k) clearance on 2025-10-06, under 510(k) number K251565.
Who is the listed applicant for Wheelchair (N817)?
The FDA 510(k) record lists Zhejiang Topwe Tools Manufacturing Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Wheelchair (N817)?
The FDA product code for Wheelchair (N817) 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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