FDA 510(k)

颈部护理治疗仪，型号：AST-905A，AST-905D，AST-905H

K号: K210756 · 2021-06-11

申请人Shenzhen Osto Technology Company Limited

决定日期2021-06-11

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

Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Company Limited. It received FDA 510(k) clearance on 2021-06-11 under 510(k) number K210756. 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 Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H?

Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H is a medical device that received FDA 510(k) clearance on 2021-06-11. The listed applicant is Shenzhen Osto Technology Company Limited. The 510(k) number is K210756.

When did Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H receive FDA 510(k) clearance?

Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H received FDA 510(k) clearance on 2021-06-11, under 510(k) number K210756.

Who is the listed applicant for Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H?

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

What is the FDA product code for Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H?

The FDA product code for Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H is NUH.

列明Shenzhen Osto Technology Company Limited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。

K213056LED面部遮光仪 K211942加热腰背治疗垫（型号：AST-622，AST-622B，AST-623，AST-623B）K211736电子肌肉刺激器（型号：AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W）K190783Health Expert 电子刺激器（型号：AST-300L）K190673Health Expert 电子刺激器

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

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