FDA.reportPublic FDA data

GEM-STIM

Primary DI
04712832961461
Brand
GEM-STIM
Company
GEMORE TECHNOLOGY CO., LTD.
Model
GM321PP(OTC)
Catalog number
GM321PP(OTC)
Device description
OTC TENS
Published
2023-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
24712832961465PackageGS130In Commercial Distribution
04712832961461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2471283296146524712832961465
04712832961461047128329614614712832961461

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
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
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
24712832961731GEM-STIMGM310PE(OTC)GM310PE(OTC)2023-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-28
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
00850080988435AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988442AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988459AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988411AUVONUAN HEALTHCARE LIMITEDNUH2026-05-06
00194346404155EquateWAL-MART STORES, INC.NUH2026-05-01
00850080988381AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850080988398AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850080988404AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850044118762iHealthiHealth Labs Inc.NUH2026-04-16
00850080988145AUVONUAN HEALTHCARE LIMITEDNUH2026-03-23
00850080988138AUVONUAN HEALTHCARE LIMITEDNUH2026-03-19
00850016867209Pixie CupPixie Cup LLCNUH2025-11-05
00810140062680RENPHOJoicom CorporationNUH2025-10-20
00810140062697RENPHOJoicom CorporationNUH2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NUH2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NUH2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNUH2025-09-29
00850073128183AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128190AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128169AVCOOADP HEALTH LIMITEDNUH2025-09-18
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NUH2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.NUH2025-09-11
00810113683379DualPulse CompactManamed, Inc.NUH2025-09-11