FDA 510(k)

Medi-Direct TENS 笔

K号: K182671 · 2019-09-21

决定日期2019-09-21

产品代码NUH

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决定实质等同

器械摘要

Medi-Direct TENS Pen is the device name listed in this FDA 510(k) record. The listed applicant is Jkh USA, LLC. It received FDA 510(k) clearance on 2019-09-21 under 510(k) number K182671. 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 Medi-Direct TENS Pen?

Medi-Direct TENS Pen is a medical device that received FDA 510(k) clearance on 2019-09-21. The listed applicant is Jkh USA, LLC. The 510(k) number is K182671.

When did Medi-Direct TENS Pen receive FDA 510(k) clearance?

Medi-Direct TENS Pen received FDA 510(k) clearance on 2019-09-21, under 510(k) number K182671.

Who is the listed applicant for Medi-Direct TENS Pen?

The FDA 510(k) record lists Jkh USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medi-Direct TENS Pen?

The FDA product code for Medi-Direct TENS Pen is NUH.

列明Jkh USA, LLC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。

K203636PlusCare 温度探头，皮肤类型：PT2252-AS，PTHP-AS，PTMQ-AS，PTSW-AS，PTSM-15AS，PTSL-AS，PTMR-AS；直肠类型：PT2252-AG，PTHP-AG，PTMQ-AG，PTSW-AG，PTSM-15AG，PTSL-AG，PTMR-AG K203635患者监护电缆 K203652血压计，U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, 血压计，U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, 血压计，U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, 血压计，U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, 血压计，U1770S, U1790s, U1710D, U1720D, U1730D, U1740D K202851Spo2传感器 K201645按摩压缩靴 K201470一次性医用口罩

查看所有 9 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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