MES 9000 Dynamic EMG

Basic Information

• Brand Name: MES 9000 Dynamic EMG
• Primary DI: D792N9200A0
• Version / Model: MES 9000 EMG
• Company Name: MYOTRONICS NOROMED, INC
• Labeler DUNS: 053824652
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-11
• Public Version: 4
• Public Version Date: 2021-06-08
• Public Version Status: Update
• Public Device Record Key: 26f6028c-cd2a-483b-8c14-d03d7d115ea5

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KZM	Device, Muscle Monitoring	Physical Medicine	890.1375	2
HCC	Device, Biofeedback	Neurology	882.5050	2
IKN	Electromyograph, Diagnostic	Physical Medicine	890.1375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60925	Virtual-display rehabilitation system, non-supportive, clinical	An assembly of devices intended to be used in a clinical setting to provide non-gravity-compensating rehabilitation therapy for neuromuscular/musculoskeletal conditions affecting the back/trunk/limbs (e.g., impaired limb function) through patient interaction with a videogame-like display prompting repeated motion of a body part (e.g., arm, hand, leg) for functional improvement; it may also provide performance feedback. It does not provide weight support and is based on motion-sensing devices [e.g., battery-powered patient-worn infrared (IR) glove, motion tracking heel pad, movement tracking camera, software] that communicate wirelessly to provide a virtual-display interface.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D792N9200A0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K013399	000