AccessGUDID - DEVICE: K7 Evaluation System-CMS (D79209940)

GUDID

Device Identifier (DI) Information

Brand Name: K7 Evaluation System-CMS
Version or Model: K7/CMS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MYOTRONICS NOROMED, INC

Primary DI Number: D79209940
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053824652 *Terms of Use

Device Description: 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 Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47556	Jaw physiology evaluation system	An assembly of mains electricity (AC-powered) devices designed to record parameters for mandibular and muscles of mastication function, primarily to aid in the diagnosis and treatment of temperomandibular joint (TMJ) and myofascial pain dysfunction (MPD) disorders, and for orthodontic, denture, and reconstruction patient evaluation. It typically uses surface electromyography to evaluate muscle groups at rest or in function; sonography to detect sounds/vibrations from the TMJ joint and/or other computer-based system to non-invasively track the mandible in function or identify its position in space relative to the skull.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NFS	Device, Jaw Tracking, For Monitoring Jaw Positions
IKN	Electromyograph, Diagnostic
KZM	Device, Muscle Monitoring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 61577118-6084-44e2-825e-5de45e14039c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 19, 2016