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FDA 510(k)

Solax 电动滑板车，型号：S302121, S302131, S302141, S302151

K号: K172440 · 2018-07-13

申请人Dongguan Prestige Sporting Goods., Ltd.
决定日期2018-07-13
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

Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Prestige Sporting Goods., Ltd.. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K172440. 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 Solax Electric Scooter, Models: S302121, S302131, S302141, S302151?

Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Dongguan Prestige Sporting Goods., Ltd.. The 510(k) number is K172440.

When did Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 receive FDA 510(k) clearance?

Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 received FDA 510(k) clearance on 2018-07-13, under 510(k) number K172440.

Who is the listed applicant for Solax Electric Scooter, Models: S302121, S302131, S302141, S302151?

The FDA 510(k) record lists Dongguan Prestige Sporting Goods., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solax Electric Scooter, Models: S302121, S302131, S302141, S302151?

The FDA product code for Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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

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