电动轮椅
K号: K250027 · 2025-02-21
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决定日期2025-02-21
产品代码INI
咨询委员会PM
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决定实质等同
器械摘要
Powered Mobility Scooter 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 2025-02-21 under 510(k) number K250027. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Powered Mobility Scooter?
Powered Mobility Scooter is a medical device that received FDA 510(k) clearance on 2025-02-21. The listed applicant is Intradin (Shanghai) Machinery Co., Ltd.. The 510(k) number is K250027.
When did Powered Mobility Scooter receive FDA 510(k) clearance?
Powered Mobility Scooter received FDA 510(k) clearance on 2025-02-21, under 510(k) number K250027.
Who is the listed applicant for Powered Mobility Scooter?
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 Powered Mobility Scooter?
The FDA product code for Powered Mobility Scooter is INI.
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：INI）
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。
K261078电动滑板车（FNS01，FNS03）Anhui Jbh Medical Apparatus Co., Ltd.K261859电动滑板车（FDB08，FDB08A，FDB12）Anhui JBH Medical Apparatus Co., Ltd.K260176移动轮椅（W3483，W3483A）Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260094电动轮椅（W3465，W3902（S50碳纤维））Zhejiang Innuovo Rehabilitation Devices Co.,LtdK261232IERO 移动代步车（IERO-01）Jochu Technology Co., Ltd.K261163Mobility Scooter (R200)Yongkang Ruihe Metal Product Co., Ltd.
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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