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J5 Myo-Monitor

FDA UDI

Class II (US FDA UDI)

by Myotronics-Noromed, Inc.

Identity

Trade Name
J5 Myo-Monitor FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
The J5 Myomonitor TENS unit is a muscle stimulator used to create a physiologically relaxed state of the muscles of mastication. FDA UDI
Model / Reference
J5 FDA UDI
Description
The J5 Myomonitor TENS unit is a muscle stimulator used to create a physiologically relaxed state of the muscles of mastication. FDA UDI

Identifiers

Catalog Number
4450 FDA UDI
Primary DI / UDI-DI
D79244500 FDA UDI
FDA Product Code
NUW FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

J5 Myo-Monitor by Myotronics-Noromed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Myotronics-Noromed, Inc.

Sources (1)

  • FDA UDI 4222f095-2309-4dfa-a0b0-4feda0a4363b 35 fields · synced Jun 8, 2026