FDA 510(k)

锂电池供电OTC TENS/EMS组合刺激器，型号Z4

K号: K251856 · 2025-11-21

决定日期2025-11-21

产品代码NUH

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决定实质等同

器械摘要

Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2025-11-21 under 510(k) number K251856. 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 Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4?

Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K251856.

When did Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 receive FDA 510(k) clearance?

Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 received FDA 510(k) clearance on 2025-11-21, under 510(k) number K251856.

Who is the listed applicant for Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4?

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

What is the FDA product code for Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4?

The FDA product code for Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 is NUH.

列明Everyway Medical Instruments 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。

K222488Everyway模拟OTC经皮神经电刺激（TENS）K213116Everyway失禁刺激系统 K202849Everyway模拟OTC经皮神经电刺激（TENS），型号N103A/N302 K202470锂电池供电OTC TENS/EMS，型号EM-6000，EM-6100，EM-6200 & EM-6300 K202317锂电池供电OTC TENS/EMS，型号EV-804，型号EV-805，&型号EV-806 K201335锂电池供电OTC TENS/EMS组合刺激器

查看所有 13 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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