FDA 510(k)

疼痛治疗设备

K号: K163611 · 2017-09-19

决定日期2017-09-19

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

Pain Therapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. It received FDA 510(k) clearance on 2017-09-19 under 510(k) number K163611. 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 Pain Therapy Device?

Pain Therapy Device is a medical device that received FDA 510(k) clearance on 2017-09-19. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. The 510(k) number is K163611.

When did Pain Therapy Device receive FDA 510(k) clearance?

Pain Therapy Device received FDA 510(k) clearance on 2017-09-19, under 510(k) number K163611.

Who is the listed applicant for Pain Therapy Device?

The FDA 510(k) record lists Guangzhou Xinbo Electronic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pain Therapy Device?

The FDA product code for Pain Therapy Device is NUH.

列明Guangzhou Xinbo Electronic 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。

K230711疼痛治疗设备（型号：P.T.S-X）K231789疼痛治疗设备（型号：P.T.S-VI，P.T.S-VII）K231164导电碳膜电极 K231167导电硅橡胶电极 K202671DR-HO's 背痛缓解系统 Pro（型号 BPRS-I 和 BPRS-II）K212948疼痛治疗设备（型号：DH-P.T.S-I，DH-P.T.S-II，DH-P.T.S-IIA，DH-P.T.S-IIB，DH-CP-I）

查看所有 12 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。