FDA 510(k)

经皮神经电刺激（TENS）和电肌肉刺激（OTC）

K号: K230163 · 2023-03-20

申请人Changsha Yuwen Medical Equipment Co., Ltd.

决定日期2023-03-20

产品代码NUH

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决定实质等同

器械摘要

TENS and EMS Stimulation (OTC) is the device name listed in this FDA 510(k) record. The listed applicant is Changsha Yuwen Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-03-20 under 510(k) number K230163. 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 TENS and EMS Stimulation (OTC)?

TENS and EMS Stimulation (OTC) is a medical device that received FDA 510(k) clearance on 2023-03-20. The listed applicant is Changsha Yuwen Medical Equipment Co., Ltd.. The 510(k) number is K230163.

When did TENS and EMS Stimulation (OTC) receive FDA 510(k) clearance?

TENS and EMS Stimulation (OTC) received FDA 510(k) clearance on 2023-03-20, under 510(k) number K230163.

Who is the listed applicant for TENS and EMS Stimulation (OTC)?

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

What is the FDA product code for TENS and EMS Stimulation (OTC)?

The FDA product code for TENS and EMS Stimulation (OTC) is NUH.

列明Changsha Yuwen Medical Equipment 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。

K230164经皮神经电刺激（TENS）和电肌肉刺激（OTC）K230174经皮神经电刺激（TENS）和电肌肉刺激（OTC）K212184经皮神经电刺激（TENS）和电肌肉刺激（OTC）

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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