Who else makes this device?

Name: MES 9000 Static Electromyography Scanner
Brand: MES 9000 Static Electromyography Scanner

Neurology › TherapeuticDevice, Biofeedback

MES 9000 Static Electromyography Scanner

Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability to eliminate extraneous electrical "noise", provides an SEMG platform you can use with confidence.…

Registry build 21.09.26

Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability to eliminate extraneous electrical “noise”, provides an SEMG platform you can use with confidence. With Noromed SEMG you know you are getting true, reliable and repeatable results. In evaluating the technological sophistication, superiority and reliability of SEMG systems, the most important factors are sensitivity (usually expressed in microvolts), the monitoring range (again usually expressed in microvolts), and how the instrument eliminates ambient electrical noise.

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 Static Electromyography Scanner
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	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number
Packaging	Pack of 2

Catalogue Numbers

Catalogue numbers for MES 9000 Static Electromyography Scanner
Catalogue number	Size	Status
Static EMG Scanner		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Ultium	Noraxon U.S.A., Inc.	23
FlexiCAP	Deymed Diagnostic S.R.O.	16
Ondamed	Ondamed Inc.	15
MyoPro	Myomo, Inc.	12
TeleMyo	Noraxon U.S.A., Inc.	12
Recording Cap G1	Deymed Diagnostic S.R.O.	8
HAL for Medical Use	Cyberdyne Inc.	8
Disc Electrode 9mm Sn (Tin)	Deymed Diagnostic S.R.O.	8
Axon	Exsurgo Limited	8
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.