FDA.reportPublic FDA data

KGL-1400-M

Primary DI
06942808241022
Brand
KGL-1400-M
Company
EasyMed Instruments Co., Ltd.
Model
KGL-1400-M
Device description
KGL-1400-M is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
Published
2021-11-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06942808241022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942808241022069428082410226942808241022

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
526951168
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942808259034Intrelief PFEIntrelief PFE2026-05-05
06942808241015KGL-1400-FKGL-1400-F2021-11-17
06942808291027ParasymParasym2021-11-17
06942808221017LogiSTIMTN-112016-12-31
06942808221086IntelliSTIM BE-28T2016-12-31
06942808221109MT-11MT-112017-12-31
06942808231023IntelliSTIMBE-28E2016-12-31
06942808261037MKIIIMKIII2016-12-31
06942808261044J Sport PlusJ Sport Plus2016-12-31
06942808221055iTENSiTENS2024-01-18
06942808291478IF-4 MultiWaveIF-4 MultiWave2024-01-19
06942808261013Ultima ComboUltima Combo2021-11-17
06942808261020Relief ComboRelief Combo2021-11-17
06942808261068Intrelief ComboIntrelief Combo2021-11-15
06942808281011Ultima NEOUltima NEO2021-11-15
06942808291409TRi-WAVETRi-WAVE2021-11-15
06942808291461NDGenNDGen2021-11-15
06942808291447Activ 8Activ 82021-09-15
06942808231016AmpcareAmpcare ES2016-12-31
06942808221031TENS U5TENS U52021-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810093080854PainPodHi-Dow International IncorporatedNUH2026-10-19
06971712720415CriterionHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-10-15
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-10-13
00850080988671AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988688AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988695AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
06978452680160ZoksiShenzhen Jiantuo Electronics Co., LtdNUH2026-09-03
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNUH2026-08-26
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNUH2026-08-18
00850085485076AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-08-17
00850085485106AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-08-17
00850087184045HomedicsFKA DISTRIBUTING CO., LLCNUH2026-07-31
06924607703550Transcutaneous Electrical Nerve StimulatorsShenzhen Kentro Medical Electronics Co.,LtdNUH2026-07-31
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-29
06971712725908MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-25
00850080988657AUVONUAN HEALTHCARE LIMITEDNUH2026-07-22
06978146200117SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
06978146200124SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
00850085485090AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-07-16
00860015112446Doctor's Choice®CLINICAL HEALTH SERVICES, INC.NUH2026-07-14
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-09
00850080988572AUVONUAN HEALTHCARE LIMITEDNUH2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-03
06978452680122AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-07-01
00850085485021AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-26
00850085485038AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-26
00850085485045AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-26
00850085485007AVCOOAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-25
00850080988473AUVONUAN HEALTHCARE LIMITEDNUH2026-06-24