FDA.reportPublic FDA data

Portable Electro-Stimulation Therapy Device

Primary DI
06976287180831
Brand
Portable Electro-Stimulation Therapy Device
Company
Guangzhou Longest Medical Technology Co., Ltd.
Model
LGT-235(US)
Published
2024-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
NYHPlaque Disclosing Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2
NYHPlaque Disclosing KitDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182108000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182108000Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd.2019-04-26NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976287180831PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976287180831069762871808316976287180831

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.

Sterilization Methods#

Method table
Method

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
06976287180336Portable Electro Stimulation Therapy DeviceLGT-2320ME2026-04-02
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
06976287180848Active Passive Trainer for Upper and Lower LimbsLGT-5100D2024-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-28
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
00850080988435AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988442AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988459AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988411AUVONUAN HEALTHCARE LIMITEDNUH2026-05-06
00194346404155EquateWAL-MART STORES, INC.NUH2026-05-01
00850080988381AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850080988398AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850080988404AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850044118762iHealthiHealth Labs Inc.NUH2026-04-16
00850080988145AUVONUAN HEALTHCARE LIMITEDNUH2026-03-23
00850080988138AUVONUAN HEALTHCARE LIMITEDNUH2026-03-19
00850016867209Pixie CupPixie Cup LLCNUH2025-11-05
00810140062680RENPHOJoicom CorporationNUH2025-10-20
00810140062697RENPHOJoicom CorporationNUH2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NUH2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NUH2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNUH2025-09-29
00850073128183AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128190AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128169AVCOOADP HEALTH LIMITEDNUH2025-09-18
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NUH2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.NUH2025-09-11
00810113683379DualPulse CompactManamed, Inc.NUH2025-09-11