MYOTRONICS NOROMED, INC

Address:5870 S. 194TH ST.,KENT,WA,98032,US

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Device Description : TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sens TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint, enabling simultaneous, bilateral capture of tissue vibrations emanating from joint sounds. Vibration (sound) data is correlated to vertical dimension of opening and closing, providing clinicians with valuable information to aid in assessing the status of articular disk and joint function.

Device Class : 1

Duns Number: 053824652

Premarket Exempt : No

Product Code : KZM, IKN, NFS, NFQ

Prescription Use : No

Device Count : 1

Device Description : TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sens TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint, enabling simultaneous, bilateral capture of tissue vibrations emanating from joint sounds. Vibration (sound) data is correlated to vertical dimension of opening and closing, providing clinicians with valuable information to aid in assessing the status of articular disk and joint function.

Device Class : 1

Duns Number: 053824652

Premarket Exempt : No

Product Code : NFQ

Prescription Use : No

Device Count : 1

Device Description : Utilizing high quality bipolar surface electrodes, surface EMG data can be taken 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.

Device Class : 1

Duns Number: 053824652

Premarket Exempt : No

Product Code : KZM, NFS, IKN

Prescription Use : No

Device Count : 1

Device Description : Multiple sensors in an extremely light weight (four ounce) spectacle-like array, Multiple sensors in an extremely light weight (four ounce) spectacle-like array, track the motion of a tiny magnet attached to the lower incisal gingiva with adhesive material. The configuration is totally non-invasive and, unlike clutches, does not interfere with patient function. The opposing sensors are wide apart permitting unobstructed access to the oral cavity for taking bite registrations and other clinical procedures, and the system is virtually immune from effects of slight head motion or nearby metallic or electronic interference. A patient education mode is included to simplify patient understanding and staff training.

Device Class :

Duns Number: 053824652

Premarket Exempt : No

Product Code : NFS, IKN, KZM

Prescription Use : No

Device Count : 1

Device Description : Utilizing high quality bipolar surface electrodes, surface EMG data can be taken 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.

Device Class : 2

Duns Number: 053824652

Premarket Exempt : No

Product Code : KZM

Prescription Use : No

Device Count : 1

- Catalog Number : 0996

Device Description : Multiple sensors in an extremely light weight (four ounce) spectacle-like array, Multiple sensors in an extremely light weight (four ounce) spectacle-like array, track the motion of a tiny magnet attached to the lower incisal gingiva with adhesive material. The configuration is totally non-invasive and, unlike clutches, does not interfere with patient function. The opposing sensors are wide apart permitting unobstructed access to the oral cavity for taking bite registrations and other clinical procedures, and the system is virtually immune from effects of slight head motion or nearby metallic or electronic interference. A patient education mode is included to simplify patient understanding and staff training.

Device Class : 1

Duns Number: 053824652

Premarket Exempt : No

Product Code : NFS

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : High quality disposable (single use) electrodes for surface electromyography (EMG).

Device Class : 2

Duns Number: 053824652

Premarket Exempt : No

Product Code : KZM, NUW

Prescription Use : No

Device Count : 1

Device Description : Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with s Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with sideburns or a beard.

Device Class : 2

Duns Number: 053824652

Premarket Exempt : No

Product Code : NUW

Prescription Use : No

Device Count : 1

Device Description : Non-jelled TENS Electrodes for use with Myomonitor.Designed for patients with s Non-jelled TENS Electrodes for use with Myomonitor.Designed for patients with sideburns or a beard.

Device Class : 2

Duns Number: 053824652

Premarket Exempt : No

Product Code : NUW

Prescription Use : No

Device Count : 1

Device Description : 36 single-use electrodes per pouch, 2 pouches per box (72 electrodes total).A re 36 single-use electrodes per pouch, 2 pouches per box (72 electrodes total).A revolutionary electrode designed especially for use with the Myomonitor and BNS-40 unit.

Device Class :

Duns Number: 053824652

Premarket Exempt : No

Product Code : NUW

Prescription Use : No

Device Count : 1