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FDA 510(k)

Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)

K-Number: K252154 · 2025-12-09

ApplicantGuangzhou Longest Medical Technology Co., Ltd.
Decision Date2025-12-09
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) is a medical device manufactured by Guangzhou Longest Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-09 under approval number K252154. 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 (LGT-2320BE, LGT-2320ME, and LGT-2320SP)?

Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) is a medical device that received FDA 510(k) clearance on 2025-12-09. It is manufactured by Guangzhou Longest Medical Technology Co., Ltd.. The 510(k) number is K252154.

When was Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) approved by the FDA?

Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) received FDA 510(k) clearance on 2025-12-09, under approval number K252154.

What company makes Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)?

Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) is manufactured by Guangzhou Longest Medical Technology Co., Ltd..

What is the FDA product code for Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)?

The FDA product code for Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) is NGX.

Related Clinical Trials

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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 Medical Technology Co., Ltd.

K250244Compression Therapy Device (LGT-2210DS) K250242Compression Therapy Device (LGT-2202DVT)

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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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