MES 9000 Muscle Tester

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…

Registry build 21.09.26

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.

6manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (5), Hebei (1).

Chinese manufacturers registered for FDA product code HCC
Manufacturer City Province Registered as Device types
Shenzhen Dongdixin Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Shenzhen Konmed Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Shenzhen XFT Medical Limited Shenzhen Guangdong Manufacturer 8
ISA Mould Engineering Limted Dongguan Guangdong Contract manufacturer 4
Qinhuangdao Huisianpu Medical Systems Inc. Qinhuangdao Hebei Manufacturer 4
Shuhai Jingwei(Shenzhen) Information Technology Co., Ltd. Shenzhen Guangdong Manufacturer 2

Record

Regulatory record for MES 9000 Muscle Tester
Listed by Myotronics-Noromed, Inc., United States
FDA product code HCC
Device type Device, Biofeedback
Device class Class 2
Regulation 21 CFR 882.5050
Establishment Repacker / relabeller, Manufacturer
510(k) K013399
Record published 2016-09-19
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 Muscle Tester
Catalogue number Size Status
Muscle Tester In distribution

Same Product Code

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Product Sold by Catalogue numbers
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HAL for Medical Use Cyberdyne Inc. 8
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Innara Health Innara Health, Inc. 7
Kangaroo Cardinal Health 200, LLC 7
SX230-1000 EMG Sensor Biometrics Ltd. 6

Showing 12 of 241. All products under Device, Biofeedback

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K111687 2011-09-29
K013399 2001-11-13
K992439 1999-08-13

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