便携式轮椅
K号: K243970 · 2025-03-07
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决定日期2025-03-07
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
Portable Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Intradin (Shanghai) Machinery Co., Ltd.. It received FDA 510(k) clearance on 2025-03-07 under 510(k) number K243970. 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 Portable Wheelchair?
Portable Wheelchair is a medical device that received FDA 510(k) clearance on 2025-03-07. The listed applicant is Intradin (Shanghai) Machinery Co., Ltd.. The 510(k) number is K243970.
When did Portable Wheelchair receive FDA 510(k) clearance?
Portable Wheelchair received FDA 510(k) clearance on 2025-03-07, under 510(k) number K243970.
Who is the listed applicant for Portable Wheelchair?
The FDA 510(k) record lists Intradin (Shanghai) Machinery Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Portable Wheelchair?
The FDA product code for Portable Wheelchair 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。
列明Intradin (Shanghai) Machinery Co., Ltd.为申报人的其他记录
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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