FDA 510(k)

VEINOPLUS 后置

K号: K251958 · 2025-12-23

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

VEINOPLUS Back is the device name listed in this FDA 510(k) record. The listed applicant is Dynapulse Medical. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K251958. 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 VEINOPLUS Back?

VEINOPLUS Back is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Dynapulse Medical. The 510(k) number is K251958.

When did VEINOPLUS Back receive FDA 510(k) clearance?

VEINOPLUS Back received FDA 510(k) clearance on 2025-12-23, under 510(k) number K251958.

Who is the listed applicant for VEINOPLUS Back?

The FDA 510(k) record lists Dynapulse Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VEINOPLUS Back?

The FDA product code for VEINOPLUS Back is NUH.

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

器械摘要

常见问题

相关临床试验

相关器械（代码：NUH）

官方来源