免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

电子脉冲刺激器

K号: K221992 · 2022-10-21

申请人Beijing Choice Electronic Technology Co., Ltd.

决定日期2022-10-21

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

Electronic Pulse Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Choice Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K221992. 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 Electronic Pulse Stimulator?

Electronic Pulse Stimulator is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Beijing Choice Electronic Technology Co., Ltd.. The 510(k) number is K221992.

When did Electronic Pulse Stimulator receive FDA 510(k) clearance?

Electronic Pulse Stimulator received FDA 510(k) clearance on 2022-10-21, under 510(k) number K221992.

Who is the listed applicant for Electronic Pulse Stimulator?

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

What is the FDA product code for Electronic Pulse Stimulator?

The FDA product code for Electronic Pulse Stimulator is NUH.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITING NCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITING NCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDED NCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Beijing Choice Electronic 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。

K232975脉搏血氧仪（MD300C228）K230587腕式脉搏血氧仪 K230172脉搏血氧仪 K220101脉搏血氧仪 K211400脉搏血氧仪 K211752红外体温计

查看所有 14 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。

↑