电动滑板车，WT-T4QP2
K号: K222729 · 2023-03-28
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决定日期2023-03-28
产品代码INI
咨询委员会PM
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Electrical Scooter, WT-T4QP2 is the device name listed in this FDA 510(k) record. The listed applicant is Wu’S Tech Co., Ltd.. It received FDA 510(k) clearance on 2023-03-28 under 510(k) number K222729. 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 Electrical Scooter, WT-T4QP2?
Electrical Scooter, WT-T4QP2 is a medical device that received FDA 510(k) clearance on 2023-03-28. The listed applicant is Wu’S Tech Co., Ltd.. The 510(k) number is K222729.
When did Electrical Scooter, WT-T4QP2 receive FDA 510(k) clearance?
Electrical Scooter, WT-T4QP2 received FDA 510(k) clearance on 2023-03-28, under 510(k) number K222729.
Who is the listed applicant for Electrical Scooter, WT-T4QP2?
The FDA 510(k) record lists Wu’S Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Electrical Scooter, WT-T4QP2?
The FDA product code for Electrical Scooter, WT-T4QP2 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Wu’S Tech 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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