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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 the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Longest Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-09 under 510(k) 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. The listed applicant is Guangzhou Longest Medical Technology Co., Ltd.. The 510(k) number is K252154.

When did Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) receive FDA 510(k) clearance?

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

Who is the listed applicant for Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)?

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

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.

Other records listing Guangzhou Longest Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.K251594truFlexSyrma Johari Medtech Limited

Official Source

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

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