J5 Myo-Monitor 4450

GUDID D79244500

The J5 Myomonitor TENS unit is a muscle stimulator used to create a physiologically relaxed state of the muscles of mastication.

MYOTRONICS NOROMED, INC

Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system
Primary Device IDD79244500
NIH Device Record Key4222f095-2309-4dfa-a0b0-4feda0a4363b
Commercial Distribution StatusIn Commercial Distribution
Brand NameJ5 Myo-Monitor
Version Model NumberJ5
Catalog Number4450
Company DUNS053824652
Company NameMYOTRONICS NOROMED, INC
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(206) 243-4214
Emailinfo@myotronics.com
Phone(206) 243-4214
Emailinfo@myotronics.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD79244500 [Primary]
HIBCCD7924450C0 [Package]
Package: Cased Unit [1 Units]
In Commercial Distribution
HIBCCD7924450J0 [Package]
Package: Boxed Unit [1 Units]
In Commercial Distribution

FDA Product Code

NUWStimulator, Muscle, Powered, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-23
Device Publish Date2016-08-18

Devices Manufactured by MYOTRONICS NOROMED, INC

D79244500 - J5 Myo-Monitor2019-10-23The J5 Myomonitor TENS unit is a muscle stimulator used to create a physiologically relaxed state of the muscles of mastication.
D79244500 - J5 Myo-Monitor2019-10-23 The J5 Myomonitor TENS unit is a muscle stimulator used to create a physiologically relaxed state of the muscles of mastication.
D79245000 - BNS-40 Home Treatment Unit2019-10-23 The BNS-40 is a miniaturized version of the Myomonitor designed to allow the patient to safely apply electrical stimulation whil
D79209830 - K7 ESG-2 Electrosonograph2018-07-06 TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint,
D79240602 - Myotrode One With Gel2018-07-06 Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with sideburns or a beard.
D79240702 - Myotrode One without Gel2018-07-06 Non-jelled TENS Electrodes for use with Myomonitor.Designed for patients with sideburns or a beard.
D79243003 - Myotrode SG Solid Gel TENS Electrodes2018-07-06 36 single-use electrodes per pouch, 2 pouches per box (72 electrodes total). A revolutionary electrode designed especially for u
D792N12013 - Norotrode 202018-07-06 NOROTRODES are silver-silver chloride electrodes for surface EMG applications. Contact surfaces pre-jelled with hypoallergenic
D792N150MES0 - MES 9000 Static Electromyography Scanner2018-07-06 Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability to eliminate extraneous electrical "no

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