FDA 510(k)

经皮神经电刺激（TENS）和电肌肉刺激（HZ9151B, HZ9151C, HZ9151D）

K号: K253740 · 2025-12-23

申请人Hong Qiangxing (Shenzhen) Electronics Limited

决定日期2025-12-23

产品代码NUH

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

TENS&EMS (HZ9151B, HZ9151C, HZ9151D) is the device name listed in this FDA 510(k) record. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K253740. 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&EMS (HZ9151B, HZ9151C, HZ9151D)?

TENS&EMS (HZ9151B, HZ9151C, HZ9151D) is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K253740.

When did TENS&EMS (HZ9151B, HZ9151C, HZ9151D) receive FDA 510(k) clearance?

TENS&EMS (HZ9151B, HZ9151C, HZ9151D) received FDA 510(k) clearance on 2025-12-23, under 510(k) number K253740.

Who is the listed applicant for TENS&EMS (HZ9151B, HZ9151C, HZ9151D)?

The FDA 510(k) record lists Hong Qiangxing (Shenzhen) Electronics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS&EMS (HZ9151B, HZ9151C, HZ9151D)?

The FDA product code for TENS&EMS (HZ9151B, HZ9151C, HZ9151D) is NUH.

列明Hong Qiangxing (Shenzhen) Electronics Limited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。

K220283经皮神经电刺激与经皮肌肉刺激（型号：SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033）K220152经皮神经电刺激与经皮肌肉刺激（型号：SM9089, SM9587, SM9592, SM9555）K220150经皮神经电刺激与经皮肌肉刺激（型号：SM9126）K201354经皮神经电刺激与经皮肌肉刺激 K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)K183154SM 电极

查看所有 7 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.K251958VEINOPLUS 后置Dynapulse Medical

官方来源

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