Cleared Traditional

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

K252154 · Guangzhou Longest Medical Technology Co., Ltd. · Physical Medicine

Dec 2025

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K252154 is an FDA 510(k) clearance for the Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP), a Stimulator, Muscle, Powered, For Muscle Conditioning (Class II — Special Controls, product code NGX), submitted by Guangzhou Longest Medical Technology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on December 9, 2025, 153 days after receiving the submission on July 9, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K252154 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 09, 2025
Decision Date	December 09, 2025
Days to Decision	153 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	NGX — Stimulator, Muscle, Powered, For Muscle Conditioning
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5850
Definition	A Powered Muscle Stimulator For Muscle Conditioning Is A Device Used For Other Than Medical Purposes To Apply An Electrical Current To Electrodes On A Person's Skin To Temporarily Affect The Stimulated Muscle's Contractile Properties, Force Output, And/or Fatigue Resistance. Unlike The Classified Powered Muscle Stimulator Devices Intended For Use In Physical Medicine And Rehabilitation, This Device Is Not Intended For Use In Patients With Medical Conditions And Is Intended Only For Muscle Conditioning Purposes.