FDA 510(k)

OTC 组合经皮神经电刺激/电肌肉刺激系统

K号: K172809 · 2017-10-18

决定日期2017-10-18

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

OTC Combo TENS/EMS System is the device name listed in this FDA 510(k) record. The listed applicant is Well-Life Healthcare Limited. It received FDA 510(k) clearance on 2017-10-18 under 510(k) number K172809. 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 OTC Combo TENS/EMS System?

OTC Combo TENS/EMS System is a medical device that received FDA 510(k) clearance on 2017-10-18. The listed applicant is Well-Life Healthcare Limited. The 510(k) number is K172809.

When did OTC Combo TENS/EMS System receive FDA 510(k) clearance?

OTC Combo TENS/EMS System received FDA 510(k) clearance on 2017-10-18, under 510(k) number K172809.

Who is the listed applicant for OTC Combo TENS/EMS System?

The FDA 510(k) record lists Well-Life Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTC Combo TENS/EMS System?

The FDA product code for OTC Combo TENS/EMS System is NUH.

列明Well-Life Healthcare 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。

K233054Well-Life 疼痛缓解（月经加）电刺激器；带月经缓解刺激器的TENS/EMS；Well-Life 疼痛缓解刺激器；月经加刺激器 K222528Well-Life 刺激/EMG 探头电极（型号：SA），Well-Life 尿失禁刺激/EMG 电极探头，Well-Life 探头电极 K220524Well-Life迷你经皮神经电刺激器（WL-23XXC/WL-23XXE系列）K213091健康生活经皮神经电刺激/电肌肉刺激/加热刺激器 K200942Well-Life服装电极（GM系列）K162663WELL LIFE Rx 无线经皮神经电刺激/电肌肉刺激器，型号 WR-2603/2603A，WR-2604/2604A 和 WR-2605/2605A

查看所有 8 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。