GEM-STIM Century 2100

GUDID 04712832960358

GM3A10T Analog TENS

GEMORE TECHNOLOGY CO., LTD.

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID04712832960358
NIH Device Record Key2ad5de0b-0029-4fb1-9a5d-d84e09e0f0d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEM-STIM
Version Model NumberCentury 2100
Catalog NumberCentury 2100
Company DUNS658435078
Company NameGEMORE TECHNOLOGY CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104712832960358 [Primary]
GS124712832960352 [Package]
Package: Carton [30 Units]
In Commercial Distribution

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-23
Device Publish Date2016-10-03

On-Brand Devices [GEM-STIM]

04712832960396GM320PE Bottom System
04712832960389GM3A10T Analog TENS
04712832960372GM320T Digital TENS
04712832960365GM320TE Digital Combo TENS+EMS
04712832960358GM3A10T Analog TENS
04712832960341OMNI GM3A50T Analog TENS with protective cover
04712832960334Butterfly Electrode
04712832960327Electrode Pad 40x40mm
04712832960303GM3A10E Analog EMS
04712832960297GM320E(C) Digital EMS
04712832960280GM3A10T(0) Analog TENS
04712832960273GM3A50E Analog EMS
04712832960266GM3A50T Analog TENS
04712832960259GM3A50T(0) Analog TENS
04712832960242Analog TENS
04712832960235Digital Combo TENS+EMS
04712832960228Digital TENS
04712832960204Digital Pre-program TENS
04712832960198Digital Pre-program EMS
04712832960075Electrode Pad 50x50mm
04712832960068Electrode Pad 40x40mm
04712832960051Lead Wire
04712832960044High Voltage Pulsed Galvanic Stimulator
04712832960037Digital TENS
04712832960020Analog Combo (TENS+EMS)
04712832960013Powered muscle stimulator, Analog EMS
04712832960006Physiotherapy Stimulator Analog TENS
04712832960426GM3A20T Analog TENS
04712832960082Electrode Pad 45mm
24712832961489OTC TENS
24712832961366Digital TENS
24712832961144Clinical type TENS
24712832960536Clinical type EMS
24712832960529Digital Combo TENS+EMS+IF
24712832960505Digital Combo TENS+EMS
24712832960499Digital EMS
24712832960482Digital TENS
24712832960475Analog Interferential
04712832960419Digital EMS
04712832960211GM322IF Interferential
24712832960512Pre-program TENS
24712832961083Interferential Stimulator
04712832961072Interferential Stimulator
04712832961065Interferential Stimulator
04712832961058Interferential Stimulator
24712832961045Interferential Stimulator
24712832961014Analog Combo (TENS+EMS)
24712832960987Analog EMS
24712832960970Analog TENS
24712832960963Analog Combo (TENS+EMS)

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