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MES 9000 Musculoskeletal System

FDA UDI

Class II (US FDA UDI)

by Myotronics-Noromed, Inc.

Identity

Trade Name
MES 9000 Musculoskeletal System FDA UDI
Generic Name
Virtual-display rehabilitation system, non-supportive, clinical FDA UDI
Device Name
Now you can have all of these capabilities in one compact system. Surface EMG, range of motion and muscle testing – may be purchased separately or in any combination. The modular design of the MES 9000 allows you to purchase any combination of modules and expand as your practice grows. The MES 9000 --- the modular system that enables you to do a complete, integrated evaluation with objective documentation that supports your diagnosis. FDA UDI
Model / Reference
N9000M FDA UDI
Description
Now you can have all of these capabilities in one compact system. Surface EMG, range of motion and muscle testing – may be purchased separately or in any combination. The modular design of the MES 9000 allows you to purchase any combination of modules and expand as your practice grows. The MES 9000 --- the modular system that enables you to do a complete, integrated evaluation with objective documentation that supports your diagnosis. FDA UDI

Identifiers

Primary DI / UDI-DI
D792N9000M0 FDA UDI
510(k) Number
K013399 FDA UDI
FDA Product Code
KZM FDA UDI
KQX FDA UDI
HCC FDA UDI
GMDN Term
Virtual-display rehabilitation system, non-supportive, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.1375 FDA UDI
888.1500 FDA UDI
882.5050 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 Musculoskeletal System 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 883bae0f-d596-417d-9dd1-e4dd109901d5 35 fields · synced May 30, 2026