FDA.reportPublic FDA data

GEM-STIM

Primary DI
04712832961249
Brand
GEM-STIM
Company
GEMORE TECHNOLOGY CO., LTD.
Model
GM390PE
Catalog number
GM390PE
Device description
Clinical type Pre-Program EMS
Published
2023-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042559000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042559000GEM-TWIN TENS/ MODELS GM3XY/ZGemore Technology Co, Ltd.2004-11-17GZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24712832961243PackageGS15In Commercial Distribution
04712832961249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2471283296124324712832961243
04712832961249047128329612494712832961249

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.

Regulatory Flags#

DUNS number
658435078
Device count
1
Serial number
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
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
00816864021682accufitMETTLER ELECTRONICS CORP.IPF2026-04-22
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
00714905117649Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00714905710024Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00810140062680RENPHOJoicom CorporationIPF2025-10-20
00810140062697RENPHOJoicom CorporationIPF2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.IPF2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.IPF2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.IPF2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.IPF2025-09-11
00810113683379DualPulse CompactManamed, Inc.IPF2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.IPF2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.IPF2025-08-21
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
00810188050052L360 Thigh SystemBioness Medical, Inc.IPF2025-07-18
00810188050175L100 Go SystemBioness Medical, Inc.IPF2025-07-18
00810188050441H200 Wireless SystemBioness Medical, Inc.IPF2025-07-18
00810188050076L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050106L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050144L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050168L100 Go SystemBioness Medical, Inc.IPF2025-07-17