Scooter，型号：R-100
K号: K182411 · 2019-06-24
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决定日期2019-06-24
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
Scooter, Model: R-100 is the device name listed in this FDA 510(k) record. The listed applicant is Yongkang Dingchang Industry & Trade Co., Ltd.. It received FDA 510(k) clearance on 2019-06-24 under 510(k) number K182411. 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 Scooter, Model: R-100?
Scooter, Model: R-100 is a medical device that received FDA 510(k) clearance on 2019-06-24. The listed applicant is Yongkang Dingchang Industry & Trade Co., Ltd.. The 510(k) number is K182411.
When did Scooter, Model: R-100 receive FDA 510(k) clearance?
Scooter, Model: R-100 received FDA 510(k) clearance on 2019-06-24, under 510(k) number K182411.
Who is the listed applicant for Scooter, Model: R-100?
The FDA 510(k) record lists Yongkang Dingchang Industry & Trade Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Scooter, Model: R-100?
The FDA product code for Scooter, Model: R-100 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Yongkang Dingchang Industry & Trade 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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