FDA 510(k)

经皮神经电刺激器，型号：KTR-405

K号: K220998 · 2022-08-24

申请人Shenzhen Kentro Medical Electronics Co., Ltd.

决定日期2022-08-24

产品代码NUH

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决定实质等同

器械摘要

Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kentro Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2022-08-24 under 510(k) number K220998. 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 Transcutaneous Electrical Nerve Stimulator, Model: KTR-405?

Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 is a medical device that received FDA 510(k) clearance on 2022-08-24. The listed applicant is Shenzhen Kentro Medical Electronics Co., Ltd.. The 510(k) number is K220998.

When did Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 received FDA 510(k) clearance on 2022-08-24, under 510(k) number K220998.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator, Model: KTR-405?

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

What is the FDA product code for Transcutaneous Electrical Nerve Stimulator, Model: KTR-405?

The FDA product code for Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 is NUH.

列明Shenzhen Kentro Medical 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。

K242332经皮电子神经刺激器（KTR-2301，KTR-2302，KTR-2341，KTR-2342，KTR-2401，KTR-2402，KTR-2411，KTR-2412，KTR-2491，KTR-2492，KTR-2493，KTR-2494）K232517经皮神经电刺激器（用于缓解疼痛）（型号：KTR-2302，KTR-2401，KTR-2402，KTR-2411，KTR-2412）K222870经皮神经电刺激器，型号：KTR-4031，KTR-4032，KTR-4012，KTR-4015，KTR-4029，KTR-4027，KTR-4026，KTR-4021，KTR-4034，KTR-4036，KTR-4037，KTR-4039 K200177低频多功能理疗仪 K200237经皮电子神经刺激器 K191982低频多功能理疗仪（型号：KTR-2230，KTR-2220，KTR-2210，KTR-2231，KTR-2221，KTR-2211，KTR-2232，KTR-2222，KTR-2212）

查看所有 10 个设备 →

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

官方来源

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