FDA 510(k)

电子刺激器

K号: K200354 · 2020-06-29

申请人Shenzhen Dongjilian Electronics Co., Ltd.

决定日期2020-06-29

产品代码NUH

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Electronic stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongjilian Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-06-29 under 510(k) number K200354. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Electronic stimulator?

Electronic stimulator is a medical device that received FDA 510(k) clearance on 2020-06-29. The listed applicant is Shenzhen Dongjilian Electronics Co., Ltd.. The 510(k) number is K200354.

When did Electronic stimulator receive FDA 510(k) clearance?

Electronic stimulator received FDA 510(k) clearance on 2020-06-29, under 510(k) number K200354.

Who is the listed applicant for Electronic stimulator?

The FDA 510(k) record lists Shenzhen Dongjilian Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electronic stimulator?

The FDA product code for Electronic stimulator is NUH.

列明Shenzhen Dongjilian Electronics 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。

K201694空气压缩治疗设备 K193354空气压缩治疗设备

相关器械（代码：NUH）

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。

K261131电肌肉刺激器（AST-105DJ，AST-105EJ，AST-105BJ，AST-105GJ，AST-303J，AST-309J，AST-310J；AST-300Q，AST-300Q-A，AST-500B；AST-500G，AST-500F；AST-500N；AST-500C，AST-500K，AST-500A；AST-300E，AST-500M，AST-500U，AST-500D；AST-500E。）Shenzhen Osto Medical Technology Co.,Ltd K260412TENS 7000 充电式 4通道（TENS 7000H）Shenzhen Dongdixin Technology Co., Ltd.K260425经皮神经电刺激/电肌肉刺激器（FT-247系列）（FT-247, FT-237）Hivox Biotek, Inc.K253896经皮神经电刺激（TENS）/电肌肉刺激器（GUSE01）Globalcare Medical Technology Co., Ltd.K253305经皮神经电刺激与电肌肉刺激（经皮神经电刺激和肌肉刺激器）（JT1065, JT1080, JT2080, JT9034）Shenzhen Jiantuo Electronics Co., Ltd.K253740经皮神经电刺激（TENS）和电肌肉刺激（HZ9151B, HZ9151C, HZ9151D）Hong Qiangxing (Shenzhen) Electronics Limited

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