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FDA 510(k)

经皮神经电刺激（TENS）和电肌肉刺激单元（SM9109A, SM9109B）

K号: K241509 · 2024-06-27

申请人Plexus Yoga, LLC Dba Chirp
决定日期2024-06-27
产品代码NUH
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决定实质等同

器械摘要

TENS&EMS units (SM9109A, SM9109B) is the device name listed in this FDA 510(k) record. The listed applicant is Plexus Yoga, LLC Dba Chirp. It received FDA 510(k) clearance on 2024-06-27 under 510(k) number K241509. 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 units (SM9109A, SM9109B)?

TENS&EMS units (SM9109A, SM9109B) is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Plexus Yoga, LLC Dba Chirp. The 510(k) number is K241509.

When did TENS&EMS units (SM9109A, SM9109B) receive FDA 510(k) clearance?

TENS&EMS units (SM9109A, SM9109B) received FDA 510(k) clearance on 2024-06-27, under 510(k) number K241509.

Who is the listed applicant for TENS&EMS units (SM9109A, SM9109B)?

The FDA 510(k) record lists Plexus Yoga, LLC Dba Chirp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS&EMS units (SM9109A, SM9109B)?

The FDA product code for TENS&EMS units (SM9109A, SM9109B) 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

官方来源

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