FDA 510(k)

组合刺激器MT9000，组合刺激器LT7102，TENS刺激器InTENSity 10

K号: K171978 · 2017-10-02

申请人Shenzhen Dongdixin Technology Co., Ltd.

决定日期2017-10-02

产品代码IPF

咨询委员会PM 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-10-02 under 510(k) number K171978. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10?

Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 is a medical device that received FDA 510(k) clearance on 2017-10-02. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K171978.

When did Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 receive FDA 510(k) clearance?

Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 received FDA 510(k) clearance on 2017-10-02, under 510(k) number K171978.

Who is the listed applicant for Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10?

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

What is the FDA product code for Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10?

The FDA product code for Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 is IPF.

列明Shenzhen Dongdixin 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。

K260412TENS 7000 充电式 4通道（TENS 7000H）K240358ShockPhysio 移动式（型号 SW3200 Basic）K213043Levator Elite（型号LE9011）K210364偏头痛数字经颅电刺激疼痛缓解器 K180331无线疼痛缓解设备 K171430失禁治疗设备，型号LT2061

查看所有 10 个设备 →

官方来源

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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。