MES 9000 Dynamic EMG

GUDID D792N9200A0

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.

MYOTRONICS NOROMED, INC

Virtual-display rehabilitation system, non-supportive, clinical

• Primary Device ID: D792N9200A0
• NIH Device Record Key: 26f6028c-cd2a-483b-8c14-d03d7d115ea5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MES 9000 Dynamic EMG
• Version Model Number: MES 9000 EMG
• Company DUNS: 053824652
• Company Name: MYOTRONICS NOROMED, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com
• Phone: 2062434214
• Email: info@myotronics.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D792N9200A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013399

FDA Product Code

• KZM: Device, Muscle Monitoring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-11

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