FDA.reportPublic FDA data

Everyway

Primary DI
04719871186039
Brand
Everyway
Company
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
Model
Z4
Device description
Electrical Muscel Stimulator (EMS)
Published
2025-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true

Product Codes#

Code, Name table
CodeName
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251856000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251856000Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4Everyway Medical Instruments Co.,Ltd2025-11-21NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719871186039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719871186039047198711860394719871186039

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
657383535
Device count
1
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719871189108iSTIMiSTIM PR-13A2023-08-30
04719871184950iSTIMiSTIM PR-02-22023-08-25
04719871185049iSTIMiSTIM PR-03A2023-08-25
04719871189092iSTIMiSTIM PR-02A2023-08-25
04719871185605iSTIMA12025-12-03
04719871186015Pain ManagementHC-890A2025-12-03
04719871189276EverywaySG50D2023-08-30
04719871189283EverywaySG43682023-08-30
04719871189290EverywaySG601472023-08-30
04719871189306EverywaySG40402023-08-30
04719871189313EverywaySG75D2023-08-30
04719871189269EverywaySG57952023-08-25
04719871183656EverywaySG70902022-03-17
04719871184202EverywaySG50502022-03-17
04719871184219EverywaySG501002022-03-17
04719871184325EverywayS551052022-03-17
04719871184332EverywayS801202022-03-17
04719871185346EverywaySG50752022-03-17
04719871185131iSTIMiSTIM EV-9062023-08-25
04719871185971Pain ManagementVB3RD2025-08-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850080988572AUVONUAN HEALTHCARE LIMITEDNGX2026-07-03
00850080988572AUVONUAN HEALTHCARE LIMITEDNUH2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-03
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06978452680122AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-07-01
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00850085485007AVCOOAnsion Technology (GuangDong) Co. Ltd.NUH2026-06-25
00850085485007AVCOOAnsion Technology (GuangDong) Co. Ltd.NGX2026-06-25
00850080988473AUVONUAN HEALTHCARE LIMITEDNGX2026-06-24
00850080988473AUVONUAN HEALTHCARE LIMITEDNUH2026-06-24
00860009281806NoodlePourang Bral Dds LLCNUH2026-06-09
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
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06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-06-02
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06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-30