FDA 510(k)

AD-2126 经皮神经电刺激器 (TENS)

K号: K222867 · 2022-12-21

决定日期2022-12-21

产品代码NUH

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决定实质等同

器械摘要

AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K222867. 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 AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)?

AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K222867.

When did AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) receive FDA 510(k) clearance?

AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) received FDA 510(k) clearance on 2022-12-21, under 510(k) number K222867.

Who is the listed applicant for AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)?

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

What is the FDA product code for AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)?

The FDA product code for AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) is NUH.

列明Andon Health Co, Ltd.为申报人的其他记录

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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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