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FDA 510(k)

Portable Electro-Stimulation Therapy Device

K-Number: K182108 · 2019-04-26

ApplicantGuangzhou Longest Science & Technology Co., Ltd.
Decision Date2019-04-26
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Portable Electro-Stimulation Therapy Device is a medical device manufactured by Guangzhou Longest Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-04-26 under approval number K182108. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portable Electro-Stimulation Therapy Device?

Portable Electro-Stimulation Therapy Device is a medical device that received FDA 510(k) clearance on 2019-04-26. It is manufactured by Guangzhou Longest Science & Technology Co., Ltd.. The 510(k) number is K182108.

When was Portable Electro-Stimulation Therapy Device approved by the FDA?

Portable Electro-Stimulation Therapy Device received FDA 510(k) clearance on 2019-04-26, under approval number K182108.

What company makes Portable Electro-Stimulation Therapy Device?

Portable Electro-Stimulation Therapy Device is manufactured by Guangzhou Longest Science & Technology Co., Ltd..

What is the FDA product code for Portable Electro-Stimulation Therapy Device?

The FDA product code for Portable Electro-Stimulation Therapy Device is NUH.

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Related PubMed Literature

PMID: 41475514 US FDA approves home-delivered tDCS for treating depression. Brain stimulation (2026) PMID: 36691763 An economic evaluation of vagus nerve stimulation as an adjunctive treatment to anti-seizure medications for the treatment of drug resistant epilepsy in the United States. Journal of medical economics (2023) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 34161248 Possible Contexts of Use for In Silico Trials Methodologies: A Consensus-Based Review. IEEE journal of biomedical and health informatics (2021)

Other Devices by Guangzhou Longest Science & Technology Co., Ltd.

K191862Compression Therapy Device Model LGT-2200SP K201845Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) K182020Portable Electro-Stimulation Therapy Device K191856Compression Therapy Device K202110MStim Drop Model: LGT-233

Related Devices (Code: NUH)

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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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