电动滑板车 (DDF100)
K号: K252275 · 2026-01-29
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决定日期2026-01-29
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
Electric Scooter (DDF100) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Nysin Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-01-29 under 510(k) number K252275. 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 Electric Scooter (DDF100)?
Electric Scooter (DDF100) is a medical device that received FDA 510(k) clearance on 2026-01-29. The listed applicant is Zhejiang Nysin Medical Co., Ltd.. The 510(k) number is K252275.
When did Electric Scooter (DDF100) receive FDA 510(k) clearance?
Electric Scooter (DDF100) received FDA 510(k) clearance on 2026-01-29, under 510(k) number K252275.
Who is the listed applicant for Electric Scooter (DDF100)?
The FDA 510(k) record lists Zhejiang Nysin Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Electric Scooter (DDF100)?
The FDA product code for Electric Scooter (DDF100) 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Zhejiang Nysin Medical 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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