K7 Evaluation System-EMG

GUDID D07920978

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.

MYOTRONICS NOROMED, INC

Jaw physiology evaluation system Jaw physiology evaluation system

• Primary Device ID: D07920978
• NIH Device Record Key: 90a1c950-ed6e-4668-be9b-f32fdd6ed215
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K7 Evaluation System-EMG
• Version Model Number: K7/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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D07920978 [Package]; Contains: D79209930; Package: [1 Units]; In Commercial Distribution
HIBCC	D79209930 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-19

Devices Manufactured by MYOTRONICS NOROMED, INC

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• D79209830 - K7 ESG-2 Electrosonograph: 2018-07-06 TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint,
• D79240602 - Myotrode One With Gel: 2018-07-06 Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with sideburns or a beard.
• D79240702 - Myotrode One without Gel: 2018-07-06 Non-jelled TENS Electrodes for use with Myomonitor.Designed for patients with sideburns or a beard.
• D79243003 - Myotrode SG Solid Gel TENS Electrodes: 2018-07-06 36 single-use electrodes per pouch, 2 pouches per box (72 electrodes total). A revolutionary electrode designed especially for u
• D792N12013 - Norotrode 20: 2018-07-06 NOROTRODES are silver-silver chloride electrodes for surface EMG applications. Contact surfaces pre-jelled with hypoallergenic
• D792N150MES0 - MES 9000 Static Electromyography Scanner: 2018-07-06 Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability to eliminate extraneous electrical "no