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FDA 510(k)

ALEVE直接疗法（ALEVE直接疗法经皮电神经刺激器）

K号: K171802 · 2018-03-07

申请人Bayer Healthcare, LLC
决定日期2018-03-07
产品代码NUH
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决定实质等同

器械摘要

ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare, LLC. It received FDA 510(k) clearance on 2018-03-07 under 510(k) number K171802. 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 ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)?

ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) is a medical device that received FDA 510(k) clearance on 2018-03-07. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K171802.

When did ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) receive FDA 510(k) clearance?

ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) received FDA 510(k) clearance on 2018-03-07, under 510(k) number K171802.

Who is the listed applicant for ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)?

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

What is the FDA product code for ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)?

The FDA product code for ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) is NUH.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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.,LtdK260412TENS 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

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