FDA 510(k)

锂电池供电OTC TENS/EMS，型号EV-804，型号EV-805，&型号EV-806

K号: K202317 · 2020-11-13

决定日期2020-11-13

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, model EV-804, model EV-805, & model EV-806 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 2020-11-13 under 510(k) number K202317. 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, model EV-804, model EV-805, & model EV-806?

Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 is a medical device that received FDA 510(k) clearance on 2020-11-13. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K202317.

When did Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 receive FDA 510(k) clearance?

Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 received FDA 510(k) clearance on 2020-11-13, under 510(k) number K202317.

Who is the listed applicant for Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806?

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, model EV-804, model EV-805, & model EV-806?

The FDA product code for Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 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。

K251856锂电池供电OTC TENS/EMS组合刺激器，型号Z4 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 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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