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MES 9000 Static Electromyography Scanner

FDA UDI

Class II (US FDA UDI)

by Myotronics-Noromed, Inc.

Identity

Trade Name
MES 9000 Static Electromyography Scanner FDA UDI
Generic Name
Patient monitoring system module, electromyographic FDA UDI
Device Name
Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability to eliminate extraneous electrical "noise", provides an SEMG platform you can use with confidence. With Noromed SEMG you know you are getting true, reliable and repeatable results. In evaluating the technological sophistication, superiority and reliability of SEMG systems, the most important factors are sensitivity (usually expressed in microvolts), the monitoring range (again usually expressed in microvolts), and how the instrument eliminates ambient electrical noise. FDA UDI
Model / Reference
Static EMG Scanner FDA UDI
Description
Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability to eliminate extraneous electrical "noise", provides an SEMG platform you can use with confidence. With Noromed SEMG you know you are getting true, reliable and repeatable results. In evaluating the technological sophistication, superiority and reliability of SEMG systems, the most important factors are sensitivity (usually expressed in microvolts), the monitoring range (again usually expressed in microvolts), and how the instrument eliminates ambient electrical noise. FDA UDI

Identifiers

Primary DI / UDI-DI
D792N150MES0 FDA UDI
510(k) Number
K013399 FDA UDI
FDA Product Code
HCC FDA UDI
KZM FDA UDI
IKN FDA UDI
GMDN Term
Patient monitoring system module, electromyographic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5050 FDA UDI
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

MES 9000 Static Electromyography Scanner 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.

Cleared under the same submission

K013399 also covers:

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 6efc8710-51c8-4ebe-a837-f087e2b7ce16 35 fields · synced Jun 8, 2026