FDA 510(k)

泰斯OTC经皮神经电刺激器型号

K号: K200838 · 2020-08-12

决定日期2020-08-12

产品代码NUH

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决定实质等同

器械摘要

Tyece OTC TENS Model is the device name listed in this FDA 510(k) record. The listed applicant is Tyece Limited. It received FDA 510(k) clearance on 2020-08-12 under 510(k) number K200838. 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 Tyece OTC TENS Model?

Tyece OTC TENS Model is a medical device that received FDA 510(k) clearance on 2020-08-12. The listed applicant is Tyece Limited. The 510(k) number is K200838.

When did Tyece OTC TENS Model receive FDA 510(k) clearance?

Tyece OTC TENS Model received FDA 510(k) clearance on 2020-08-12, under 510(k) number K200838.

Who is the listed applicant for Tyece OTC TENS Model?

The FDA 510(k) record lists Tyece Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tyece OTC TENS Model?

The FDA product code for Tyece OTC TENS Model is NUH.

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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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。

器械摘要

常见问题

相关临床试验

相关器械（代码：NUH）

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