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FDA 510(k)

Portable Electro-Stimulation Therapy Device

K-Number: K182020 · 2020-09-17

ApplicantGuangzhou Longest Science & Technology Co., Ltd.
Decision Date2020-09-17
Product CodeNGX
Advisory CommitteePM
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 2020-09-17 under approval number K182020. The device is classified under product code NGX. It was reviewed by the PM 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 2020-09-17. It is manufactured by Guangzhou Longest Science & Technology Co., Ltd.. The 510(k) number is K182020.

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

Portable Electro-Stimulation Therapy Device received FDA 510(k) clearance on 2020-09-17, under approval number K182020.

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 NGX.

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Related PubMed Literature

PMID: 41523432 Development of a Low-Cost Portable Iontophoresis Device. Cureus (2025) PMID: 41470022 Low-intensity pulsed ultrasound for peripheral nerve regeneration: mechanobiological mechanisms and translational potential. Journal of translational medicine (2025) PMID: 41072144 Use of Bayesian decision analysis in the design of patient-centered clinical trials for kidney failure devices. Computers in biology and medicine (2025) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025)

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

K191862Compression Therapy Device Model LGT-2200SP K182108Portable Electro-Stimulation Therapy Device K201845Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) K191856Compression Therapy Device K202110MStim Drop Model: LGT-233

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Official Source

View on FDA Database →

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