Duns Number:053824652
Device Description: TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibr 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.
Catalog Number
-
Brand Name
K7 Evaluation System-ESG
Version/Model Number
K7/ESG
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IKN
Product Code Name
Electromyograph, Diagnostic
Public Device Record Key
016627f5-d957-44f7-9967-b435e4cb83dd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 19, 2016
Package DI Number
D0792009780
Quantity per Package
1
Contains DI Package
D79209750
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |