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MES 9000 Muscle Tester

FDA UDI

Class II (US FDA UDI)

by Myotronics-Noromed, Inc.

Identity

Trade Name
MES 9000 Muscle Tester FDA UDI
Generic Name
Virtual-display rehabilitation system, non-supportive, clinical FDA UDI
Device Name
Noromed computerized manual muscle testing offers manual muscle testing at its best by bringing science to what once was an art. The muscle testing hardware includes an ergonomic force gauge and five attachments to choose from which provide easy, comfortable testing of all muscle groups - large and small. Now you can perform real time strength testing - quickly and easily - and all fully documented by the computer interface. The flexibility of the system allows you to use pre-programmed established protocols or create your own. Designed to meet your needs, the software calculates the statistics appropriate to each test as well as generating a wide variety of documentation to fit your specific needs. This documentation includes: Supportive documentation reports which contain the graphic reports and profiles of the actual test data. Reports included are: •A composite report of individual test results by protocol and muscles tested as well as calculated deficits. •A test comparison report which collects and displays the patient's historical results. •A Myotest data report which presents both statistical data and graphical data of the individual test broken down by trial. FDA UDI
Model / Reference
Muscle Tester FDA UDI
Description
Noromed computerized manual muscle testing offers manual muscle testing at its best by bringing science to what once was an art. The muscle testing hardware includes an ergonomic force gauge and five attachments to choose from which provide easy, comfortable testing of all muscle groups - large and small. Now you can perform real time strength testing - quickly and easily - and all fully documented by the computer interface. The flexibility of the system allows you to use pre-programmed established protocols or create your own. Designed to meet your needs, the software calculates the statistics appropriate to each test as well as generating a wide variety of documentation to fit your specific needs. This documentation includes: Supportive documentation reports which contain the graphic reports and profiles of the actual test data. Reports included are: •A composite report of individual test results by protocol and muscles tested as well as calculated deficits. •A test comparison report which collects and displays the patient's historical results. •A Myotest data report which presents both statistical data and graphical data of the individual test broken down by trial. FDA UDI

Identifiers

Primary DI / UDI-DI
D792N9600A0 FDA UDI
510(k) Number
K013399 FDA UDI
FDA Product Code
HCC FDA UDI
KZM FDA UDI
GMDN Term
Virtual-display rehabilitation system, non-supportive, clinical 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: Virtual-display rehabilitation system, non-supportive, clinical

MES 9000 Muscle Tester by Myotronics-Noromed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Virtual-display rehabilitation system, non-supportive, clinical.

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 8cf90e98-f089-42ef-8e0e-0f6df10cbef3 35 fields · synced May 30, 2026