FDA 510(k)

经皮神经电刺激器（TENS WMPS2-1）

K号: K231425 · 2024-03-27

申请人Wuxi Jiajian Medical Instrument Co., Ltd.

决定日期2024-03-27

产品代码NUH

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决定实质等同

器械摘要

Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Jiajian Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2024-03-27 under 510(k) number K231425. 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 (TENS WMPS2-1)?

Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) is a medical device that received FDA 510(k) clearance on 2024-03-27. The listed applicant is Wuxi Jiajian Medical Instrument Co., Ltd.. The 510(k) number is K231425.

When did Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) received FDA 510(k) clearance on 2024-03-27, under 510(k) number K231425.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)?

The FDA 510(k) record lists Wuxi Jiajian Medical Instrument 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 (TENS WMPS2-1)?

The FDA product code for Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) is NUH.

列明Wuxi Jiajian Medical Instrument 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。

K244030针刺激器（CMNS6-1 PLUS, CMNS6-3）K222879经皮神经电刺激器（型号：TENS WMPS6-1）K202861针刺激器 K202893经皮神经电刺激器 K192568嘉健自粘电极

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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