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K7 EMG Electromyograph

FDA UDI

Class II (US FDA UDI)

by Myotronics-Noromed, Inc.

Identity

Trade Name
K7 EMG Electromyograph FDA UDI
Generic Name
Patient monitoring system module, electromyographic FDA UDI
Device Name
Utilizing high quality bipolar surface electrodes, surface EMG data can be taken from up to eight muscle sites simultaneously and in real time. The program permits taking electromyography data either at rest or in function. All eight channels may be displayed simultaneously, for a period of 15 seconds (one visual screen width). The K7/EMG signal processing circuitry provides unsurpassed protection against system noise or motion artifact. The patient education mode permits quick and easy patient education as to status of masticatory muscles. FDA UDI
Model / Reference
EMG FDA UDI
Description
Utilizing high quality bipolar surface electrodes, surface EMG data can be taken from up to eight muscle sites simultaneously and in real time. The program permits taking electromyography data either at rest or in function. All eight channels may be displayed simultaneously, for a period of 15 seconds (one visual screen width). The K7/EMG signal processing circuitry provides unsurpassed protection against system noise or motion artifact. The patient education mode permits quick and easy patient education as to status of masticatory muscles. FDA UDI

Identifiers

Catalog Number
0995 FDA UDI
Primary DI / UDI-DI
D79209950 FDA UDI
FDA Product Code
KZM FDA UDI
GMDN Term
Patient monitoring system module, electromyographic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.1375 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

No

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: Patient monitoring system module, electromyographic

K7 EMG Electromyograph by Myotronics-Noromed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient monitoring system module, electromyographic.

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 a822ed6c-e4a7-4fa0-99e0-6a519bc9b092 35 fields · synced May 30, 2026