FDA 510(k)

S21 经皮神经电刺激器

K号: K233095 · 2024-03-01

决定日期2024-03-01

产品代码NUH

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决定实质等同

器械摘要

S21 OTC Transcutaneous Electrical Nerve Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Micro Current Technology, Inc.. It received FDA 510(k) clearance on 2024-03-01 under 510(k) number K233095. 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 S21 OTC Transcutaneous Electrical Nerve Stimulator?

S21 OTC Transcutaneous Electrical Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2024-03-01. The listed applicant is Micro Current Technology, Inc.. The 510(k) number is K233095.

When did S21 OTC Transcutaneous Electrical Nerve Stimulator receive FDA 510(k) clearance?

S21 OTC Transcutaneous Electrical Nerve Stimulator received FDA 510(k) clearance on 2024-03-01, under 510(k) number K233095.

Who is the listed applicant for S21 OTC Transcutaneous Electrical Nerve Stimulator?

The FDA 510(k) record lists Micro Current Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S21 OTC Transcutaneous Electrical Nerve Stimulator?

The FDA product code for S21 OTC Transcutaneous Electrical Nerve Stimulator is NUH.

列明Micro Current Technology, Inc.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 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

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