FDA 510(k)

经皮神经电刺激与经皮肌肉刺激（型号：SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033）

K号: K220283 · 2022-05-02

申请人Hong Qiangxing (Shenzhen) Electronics Limited

决定日期2022-05-02

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

TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) is the device name listed in this FDA 510(k) record. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. It received FDA 510(k) clearance on 2022-05-02 under 510(k) number K220283. 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 & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)?

TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) is a medical device that received FDA 510(k) clearance on 2022-05-02. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K220283.

When did TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) receive FDA 510(k) clearance?

TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) received FDA 510(k) clearance on 2022-05-02, under 510(k) number K220283.

Who is the listed applicant for TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)?

The FDA 510(k) record lists Hong Qiangxing (Shenzhen) Electronics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)?

The FDA product code for TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) is NUH.

列明Hong Qiangxing (Shenzhen) Electronics 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。

K253740经皮神经电刺激（TENS）和电肌肉刺激（HZ9151B, HZ9151C, HZ9151D）K220152经皮神经电刺激与经皮肌肉刺激（型号：SM9089, SM9587, SM9592, SM9555）K220150经皮神经电刺激与经皮肌肉刺激（型号：SM9126）K201354经皮神经电刺激与经皮肌肉刺激 K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)K183154SM 电极

查看所有 7 个设备 →

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。