FDA.reportPublic FDA data

GEM-STIM

Primary DI
04712832960334
Brand
GEM-STIM
Company
GEMORE TECHNOLOGY CO., LTD.
Model
Butterfly Electrode
Catalog number
Butterfly Electrode
Device description
Butterfly Electrode
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14712832960331PackageGS150In Commercial Distribution
24712832960338PackageGS1400In Commercial Distribution
04712832960334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471283296033114712832960331
2471283296033824712832960338
04712832960334047128329603344712832960334

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. 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
658435078
Device count
1
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04712832961454GEM-STIMGM310PP(OTC)GM310PP(OTC)2023-09-08
04712832961478GEM-STIMGM330PP(OTC)GM330PP(OTC)2023-09-08
04712832961683GEM-STIMGM310PE(OTC)GM310PE(OTC)2023-09-08
04712832961690GEM-STIMGM320PE(OTC)GM320PE(OTC)2023-09-08
04712832961706GEM-STIMGM330PE(OTC)GM330PE(OTC)2023-09-08
04712832961713GEM-STIMGM340PE(OTC)GM340PE(OTC)2023-09-08
04712832961720GEM-STIMGM350PE(OTC)GM350PE(OTC)2023-09-08
04712832961737GEM-STIMGM310PE(OTC)GM310PE(OTC)2023-09-08
04712832961744GEM-STIMGM320PE(OTC)GM320PE(OTC)2023-09-08
04712832961751GEM-STIMGM330PE(OTC)GM330PE(OTC)2023-09-08
04712832961768GEM-STIMGM340PE(OTC)GM340PE(OTC)2023-09-08
04712832961782GEM-STIMGM320PP(OTC)GM320PP(OTC)2023-09-08
24712832961458GEM-STIMGM310PP(OTC)GM310PP(OTC)2023-09-08
04712832961461GEM-STIMGM321PP(OTC)GM321PP(OTC)2023-09-08
24712832961472GEM-STIMGM330PP(OTC)GM330PP(OTC)2023-09-08
24712832961687GEM-STIMGM310PE(OTC)GM310PE(OTC)2023-09-08
24712832961694GEM-STIMGM320PE(OTC)GM320PE(OTC)2023-09-08
24712832961700GEM-STIMGM330PE(OTC)GM330PE(OTC)2023-09-08
24712832961717GEM-STIMGM340PE(OTC)GM340PE(OTC)2023-09-08
24712832961724GEM-STIMGM350PE(OTC)GM350PE(OTC)2023-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973602730894MEDLOTTOP-RANK HEALTH CARE CO., LTD.GXY2026-06-08
08720791379032Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379049Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379063Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379087Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
00816312028072Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-06-01
00850055335004iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335011iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335028iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02