K7 EMG Electromyograph

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…

Registry build 21.09.26

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.

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 K7 EMG Electromyograph
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
Record published 2016-08-18
Record revised 2018-03-29 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for K7 EMG Electromyograph
Catalogue number Size Status
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
MES 9000 Dynamic EMG Myotronics-Noromed, Inc. 1
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 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