FDA 510(k)

TENS 7000 充电式 4通道（TENS 7000H）

K号: K260412 · 2026-06-26

申请人Shenzhen Dongdixin Technology Co., Ltd.

决定日期2026-06-26

产品代码NUH

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决定实质等同

器械摘要

TENS 7000 Rechargeable 4 Channel (TENS 7000H) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-26 under 510(k) number K260412. 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 TENS 7000 Rechargeable 4 Channel (TENS 7000H)?

TENS 7000 Rechargeable 4 Channel (TENS 7000H) is a medical device that received FDA 510(k) clearance on 2026-06-26. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K260412.

When did TENS 7000 Rechargeable 4 Channel (TENS 7000H) receive FDA 510(k) clearance?

TENS 7000 Rechargeable 4 Channel (TENS 7000H) received FDA 510(k) clearance on 2026-06-26, under 510(k) number K260412.

Who is the listed applicant for TENS 7000 Rechargeable 4 Channel (TENS 7000H)?

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

What is the FDA product code for TENS 7000 Rechargeable 4 Channel (TENS 7000H)?

The FDA product code for TENS 7000 Rechargeable 4 Channel (TENS 7000H) is NUH.

列明Shenzhen Dongdixin Technology 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。

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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 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 K251958VEINOPLUS 后置Dynapulse Medical

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