Duns Number:053824652
Device Description: Multiple sensors in an extremely light weight (four ounce) spectacle-like array, track the 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.
Catalog Number
-
Brand Name
K7 Evaluation System-CMS
Version/Model Number
K7/CMS
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
61577118-6084-44e2-825e-5de45e14039c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 19, 2016
Package DI Number
D79209780
Quantity per Package
1
Contains DI Package
D79209940
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 |