MediMax Tech

GUDID 00817325020701

Innostim Tens 2k Unit - Digital Tens Unit

MEDIMAX TECH INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID00817325020701
NIH Device Record Key4a2426de-6447-47e6-87d8-dfd24bfd587a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMediMax Tech
Version Model NumberInnostim Tens 2k Unit
Company DUNS927071162
Company NameMEDIMAX TECH INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com
Phone855-633-4629
Emailmalorie.c@medimaxtech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817325020701 [Primary]
GS110817325020708 [Package]
Package: Inner Box [5 Units]
In Commercial Distribution
GS120817325020705 [Package]
Contains: 10817325020708
Package: Master Case [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2016-08-02

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20817325023201MXF47TC-50 Adult Round Carbon Snap Foam ECG Electrodes - SINGLE PACK OF 50
20817325023195MXNSR15A ELECTRODE, PRE-WIRED, RADIO-TRANSLUCENT, 24 IN, 26X40MM SQUARE- SINGLE PACK OF 3
20817325023188MXM55S-50 ELECTRODE WITH MICRO-PORE TAPE- SINGLE PACK OF 50
20817325023171MXC38SC-5 ELECTRODE SOFT CLOTH, RADIO-TRANSLUCENT, RE-POSITIONAL- SINGLE STRIP OF 5
20817325023164MXC38SC-3 ELECTRODE SOFT CLOTH, RADIO-TRANSLUCENT, RE-POSITIONAL- SINGLE STRIP OF 3
20817325023157MXC43T-50 ELECTRODE SM SIZE, SOFT CLOTH - SINGLE PACK OF 50
20817325023140MXM43S-50 ELECTRODE, MICRO-PORE , SQUARE, PEDIATRIC- SINGLE PACK OF 50
20817325023133MXF47T-3 ELECTRODE FOAM, 47MM TEAR DROP- SINGLE PACK OF 3
20817325023126MXT55R-50 ELECTRODE CLEAR TAPE, 55MM ROUND- SINGLE PACK OF 50
20817325023119MXF55R-50 ELECTRODE FOAM, 55MM ROUND, SINGLE PACK OF 50
20817325023102MXF43T-50 ELECTRODE FOAM, 45MM TEAR DROP, RADIO-TRANSLUCENT- SINGLE PACK OF 50
20817325023096MXC47T-50 ELECTRODE CLOTH, 47MM TEARDROP, DIAPHORETIC- SINGLE PACK OF 50
20817325023089EcoEvRNHT-15 Standard Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade
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20817325023058Standard Smoke Evacuation Pencil with 2.5"Ceramic Coated Non Stick Blade with Holster
20817325023041EcoEvBNHT-15 Standard Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade
20817325023034EcoEvBNHT-10 Standard Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade
20817325023027EcoEvBNH-15 Standard Smoke Evacuation Pencil with 2.5"Ceramic Coated Non Stick Blade with Holste
20817325023010EcoEvBNH-10 Standard Smoke Evacuation Pencil with 2.5"Ceramic Coated Non Stick Blade with Holste
20817325023003EvBNHT-15 Telescopic Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade
20817325022990EvBNHT-10 Telescopic Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade
20817325022983EvBNH-15 Telescopic Smoke Evacuation Pencil with 2.5" Ceramic Coated Non Stick Blade with Holste
20817325022976EvBNH-10 Telescopic Smoke Evacuation Pencil with 2.5" Ceramic Coated Non Stick Blade with Holste
20817325022969NCS-SG15-15 MAXNCS Trio Cloth Electrode 1.5m - Single Pack
20817325022952SG15G-15 Ground Cloth Surface Electrode 1.5m - Single Pack
20817325022945SG15R-15 Four Disk Cloth Surface Electrode 1.5m - Single Pack
20817325022938EvBNHT Telescopic Push Button ESU Smoke Pencil With Insulated Blade - Single Pack
20817325022921ONMX52P Split Horizontal Corded Foam Grounding Plate- New Oversized Gel- Neo-Natal Use -Single P
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20817325022877MX42P Split Vertical Corded Foam Grounding Plate- Single Pack
20817325022860PMX42U Split Vertical Non-Corded Foam Grounding Plate- Pediatric Use -Single Pack
20817325022853MX42U Split Vertical Non-Corded Foam Grounding Plate- Single Pack
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20817325022822NMX41P Solid Vertical Corded Foam Grounding Plate- Neo-Natal Use -Single Pack
10817325022818PMX41P Solid Vertical Corded Foam Grounding Plate- Pediatric Use -Single Pack
20817325022808MX41P Solid Vertical Corded Foam Grounding Plate- Single Pack
20817325022792PMX41U Solid Vertical Non-Corded Foam Grounding Plate- Pediatric Use -Single Pack
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20817325022778MX51P Solid Horizontal Corded Foam Grounding Plate -Single Pack
00817325022767MX51U Solid Horizontal Non-Corded Foam Grounding Plate -Single Pack
20817325022754MXC55R-30 ECG: Cloth, Round 55mm, Solid Gel, ECG Electrode, 30pcs/Pack, 600pcs/Box, 6000pcs/Mast
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