FDA.reportPublic FDA data

GEM-STIM

Primary DI
04712832961232
Brand
GEM-STIM
Company
GEMORE TECHNOLOGY CO., LTD.
Model
GM390PP
Catalog number
GM390PP
Device description
Clinical type Pre-Program TENS
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
GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2

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
24712832961236PackageGS15In Commercial Distribution
04712832961232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2471283296123624712832961236
04712832961232047128329612324712832961232

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
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
00714905710024Fab StimDrive Devilbiss HealthcareGZJ2026-02-06
00810140062680RENPHOJoicom CorporationGZJ2025-10-20
00810140062697RENPHOJoicom CorporationGZJ2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.GZJ2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.GZJ2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.GZJ2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.GZJ2025-09-11
00810113683379DualPulse CompactManamed, Inc.GZJ2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.GZJ2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.GZJ2025-08-21
08809851470091EVE Synergy; EVE TitanWEERO Co., Ltd.GZJ2025-06-24
00661168000037Reliefband® Sport - BlackRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000044Reliefband® Sport - Soft GreyRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000167Reliefband® 50 HoursRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00661168000181Reliefband® Premier PlusRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
00815290018303Therapist’s Choice® TENS 12MT Small Carrying CaseCLINICAL HEALTH SERVICES, INC.GZJ2024-12-21
14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
00810113683218ManaMedManamed, Inc.GZJ2024-04-30
B786SBM1AB0110actiTENSSUBLIMEDGZJ2024-04-24
20192253018360Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
20192253018377Uni-PatchCardinal Health 200, LLCGZJ2024-02-28
B731P12T109TrueReliefTruerelief, LLCGZJ2024-01-08
00815290019409ePower® T1 TENS UNITCLINICAL HEALTH SERVICES, INC.GZJ2023-09-17