Portable Electro-Stimulation Therapy Device

Primary DI
06971410780025
Brand
Portable Electro-Stimulation Therapy Device
Company
Guangzhou Longest Science & Technology Co., Ltd.
Model
LGT-231(US)
Published
2020-10-30
Public version status
Update
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
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
NYNStimulator, Electrical, Transcutaneous, For Arthritis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2
NYNStimulator, Electrical, Transcutaneous, For ArthritisNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182020000Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Science & Technology Co., Ltd.2020-09-17NGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971410780025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971410780025069714107800256971410780025

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit 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 a portable wearable device such as a wristband. 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
527141843
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971410780254Compression Therapy DeviceLGT-2201DVT2020-10-16
06971410780063Portable Electro-Stimulation Therapy DeviceLGT-2332021-12-02
06971410780032Portable Electro-Stimulation Therapy DeviceLGT-232(US)2020-11-06
06971410780049Portable Electro-Stimulation Therapy DeviceLGT-235(US)2019-11-03
06971410780261Radial Pressure Pulse Therapy DeviceLGT-2500S, config II2020-10-15
06971410780278Radial Pressure Pulse Therapy DeviceLGT-2500S, config III2020-10-15
06971410780346Active Passive Trainer for Upper and Lower LimbsLGT-5100D2020-10-20
06971410780100Compression Therapy DeviceLGT-2200SP2019-11-03

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