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FDA 510(k)

Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10

K-Number: K171978 · 2017-10-02

ApplicantShenzhen Dongdixin Technology Co., Ltd.
Decision Date2017-10-02
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K171978.

When was Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 approved by the FDA?

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

What company makes Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10?

Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 is manufactured by Shenzhen Dongdixin Technology Co., Ltd..

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.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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