MES 9000 Dynamic EMG

The Dynamic SEMG module of the MES 9000 allows for the recording of up to 8 channels of SEMG simultaneously. The MES 9000 offers you the flexibility to monitor and record the data in its…

Registry build 21.09.26

The Dynamic SEMG module of the MES 9000 allows for the recording of up to 8 channels of SEMG simultaneously. The MES 9000 offers you the flexibility to monitor and record the data in its raw state or as integrated data. The powerful and user-friendly software simplifies the recording of multiple muscle groups of antagonist and synergist muscles to facilitate assessment and case documentation. In addition, the system includes pre-programmed protocols and analysis for assessment, muscle education and relaxation training. The clinician may also program custom protocols – quickly and simply.

1manufacturer
1catalogue number
2510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KZM
Manufacturer City Province Registered as Device types
Jiangyin Sinbon Electronics Co Ltd Jiangyin Jiangsu Contract manufacturer 13

Record

Regulatory record for MES 9000 Dynamic EMG
Listed by Myotronics-Noromed, Inc., United States
FDA product code KZM
Device type Device, Muscle Monitoring
Device class Class 2
Regulation 21 CFR 890.1375
Establishment Repacker / relabeller, Manufacturer
510(k) K013399
Record published 2017-02-11
Record revised 2021-06-08 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for MES 9000 Dynamic EMG
Catalogue number Size Status
MES 9000 EMG In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
HindexRV HHS Systems, Inc. 2
M-Scan BIO-Research Associates, Inc. 2
BioPAK BIO-Research Associates, Inc. 1
K7 Evaluation System-EMG Myotronics-Noromed, Inc. 1
Nox A1 Starter Sensor Kit, Pediatric Nox Medical Ehf 1
Teethan BTS SPA 1
Nox A1 Carry Case Nox Medical Ehf 1
Monotrode 101 Myotronics-Noromed, Inc. 1
BioEMG BIO-Research Associates, Inc. 1
MES 9000 Musculoskeletal System Myotronics-Noromed, Inc. 1
K7 EMG Electromyograph Myotronics-Noromed, Inc. 1
K7 Evaluation System-ESG Myotronics-Noromed, Inc. 1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K003287 2000-11-06
K992694 1999-09-10

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer