FDA.reportPublic FDA data

Portable Electro Stimulation Therapy Device

Primary DI
06976287180336
Brand
Portable Electro Stimulation Therapy Device
Company
Guangzhou Longest Medical Technology Co., Ltd.
Model
LGT-2320ME
Published
2026-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NYNStimulator, Electrical, Transcutaneous, For Arthritis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NYNStimulator, Electrical, Transcutaneous, For ArthritisNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252154000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252154000Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.2025-12-09NGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976287180336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976287180336069762871803366976287180336

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Regulatory Flags#

DUNS number
550274189
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976287180787Active Passive Trainer for Upper and Lower LimbsLGT-5100P2026-04-14
06976287181012Compression Therapy DeviceLGT-2210DS2026-04-14
06976287180343Portable Electro Stimulation Therapy DeviceLGT-2320BE2026-04-02
06976287180350Portable Electro Stimulation Therapy DeviceLGT-2320SP2026-04-02
06976287181005Deep Oscillation Therapy DeviceLGT-2360S2024-09-20
06976287180855Electrostatic Oscillation Therapy DeviceLGT-2360S2024-07-18
06976287180992PowerPulse DeviceLGT-2520AP2024-09-20
06976287180862Radial Pressure Pulse Therapy DeviceLGT-2500S, config II2024-07-22
06976287180879Radial Pressure Pulse Therapy DeviceLGT-2500S, config III2024-07-22
06976287180886Focused Shock Wave Therapy DeviceLGT-2520AP2024-07-22
06976287180466Radial Pressure Pulse Therapy DeviceLGT-2500X2024-07-18
06976287180794Compression Therapy DeviceLGT-2200SP2024-07-18
06976287180800Portable Electro-Stimulation Therapy DeviceLGT-231(US)2024-07-18
06976287180817Portable Electro-Stimulation Therapy DeviceLGT-232(US)2024-07-18
06976287180824Portable Electro-Stimulation Therapy DeviceLGT-2332024-07-18
06976287180831Portable Electro-Stimulation Therapy DeviceLGT-235(US)2024-07-18
06976287180848Active Passive Trainer for Upper and Lower LimbsLGT-5100D2024-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874125305Muscle StimulatorShenzhen Yiran Intelligence Co., Ltd.NGX2026-05-08
00810060832851Venus NovaVenus Concept Inc.NGX2026-04-15
00810093080786PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810140062680RENPHOJoicom CorporationNGX2025-10-20
00810140062697RENPHOJoicom CorporationNYN2025-10-20
00810140062697RENPHOJoicom CorporationNGX2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NGX2025-10-03
00810113683782ManaRecovery Stimulation System Manamed, Inc.NYN2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NGX2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NYN2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNGX2025-09-29
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NGX2025-09-11
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NYN2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.NYN2025-09-11
00810113683379DualPulse CompactManamed, Inc.NYN2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.NYN2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NYN2025-08-21
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NGX2025-08-21
00092237621974TwinStimDrive Devilbiss HealthcareNGX2025-08-15
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.NGX2025-07-21
00194346469680EQUATEWAL-MART STORES, INC.NGX2025-06-13
16971712727657AUVONHong Qiangxing (Shen Zhen) Electronics LimitedNGX2025-03-31
00768627001632NorcoNORTH COAST MEDICAL, INC.NGX2025-03-26
00092237626849TENS 7000Drive Devilbiss HealthcareNGX2025-01-21
00092237626870TENS 7000Drive Devilbiss HealthcareNYN2025-01-06
00092237626856TENS 7000Drive Devilbiss HealthcareNYN2025-01-06
00092237626863TENS 7000Drive Devilbiss HealthcareNYN2025-01-06
00815290018303Therapist’s Choice® TENS 12MT Small Carrying CaseCLINICAL HEALTH SERVICES, INC.NGX2024-12-21
16977159460065versatone-xtGymmax Technology (Shenzhen) Co., Ltd.NGX2024-12-19