FDA 510(k)

低频刺激器（型号：AST-645，AST-646）

K号: K212989 · 2021-11-22

决定日期2021-11-22

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

Low-frequency Stimulator (Model: AST-645, AST-646) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-22 under 510(k) number K212989. 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 Low-frequency Stimulator (Model: AST-645, AST-646)?

Low-frequency Stimulator (Model: AST-645, AST-646) is a medical device that received FDA 510(k) clearance on 2021-11-22. The listed applicant is Shenzhen Osto Technology Co., Ltd.. The 510(k) number is K212989.

When did Low-frequency Stimulator (Model: AST-645, AST-646) receive FDA 510(k) clearance?

Low-frequency Stimulator (Model: AST-645, AST-646) received FDA 510(k) clearance on 2021-11-22, under 510(k) number K212989.

Who is the listed applicant for Low-frequency Stimulator (Model: AST-645, AST-646)?

The FDA 510(k) record lists Shenzhen Osto Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Low-frequency Stimulator (Model: AST-645, AST-646)?

The FDA product code for Low-frequency Stimulator (Model: AST-645, AST-646) is NUH.

列明Shenzhen Osto Technology Co., Ltd.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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