FDA 510(k)

TENS7000可充电式（型号：TENS7000可充电式）

K号: K230829 · 2023-04-26

申请人Chongqing Rob Linka Science and Technology Co., Ltd.

决定日期2023-04-26

产品代码NUH

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决定实质等同

器械摘要

TENS7000 Rechargeable (Model:TENS7000 Rechargeable) is the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Rob Linka Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-04-26 under 510(k) number K230829. 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 TENS7000 Rechargeable (Model:TENS7000 Rechargeable)?

TENS7000 Rechargeable (Model:TENS7000 Rechargeable) is a medical device that received FDA 510(k) clearance on 2023-04-26. The listed applicant is Chongqing Rob Linka Science and Technology Co., Ltd.. The 510(k) number is K230829.

When did TENS7000 Rechargeable (Model:TENS7000 Rechargeable) receive FDA 510(k) clearance?

TENS7000 Rechargeable (Model:TENS7000 Rechargeable) received FDA 510(k) clearance on 2023-04-26, under 510(k) number K230829.

Who is the listed applicant for TENS7000 Rechargeable (Model:TENS7000 Rechargeable)?

The FDA 510(k) record lists Chongqing Rob Linka Science and Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS7000 Rechargeable (Model:TENS7000 Rechargeable)?

The FDA product code for TENS7000 Rechargeable (Model:TENS7000 Rechargeable) is NUH.

列明Chongqing Rob Linka Science and 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。

K233067无线经皮神经电刺激（TENS）与电肌肉刺激（EMS）（型号SM9110，SM9113，SM9116）K233070Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)K233092疼痛治疗设备（SM9075，SM9910，SM9067，SM9587W）

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

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