Duns Number:428484518
Device Description: BTS TMJOINT is a wireless surface electromyograph to measure thedifferential influence of BTS TMJOINT is a wireless surface electromyograph to measure thedifferential influence of the occlusal function through indices validatedand published in scientific literature
Catalog Number
BTSEMB1BM
Brand Name
TMJOINT
Version/Model Number
1.0
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
41ad9536-823d-4a0d-8786-4e3ce769f248
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 12, 2017
Package DI Number
B179TMJ1
Quantity per Package
1
Contains DI Package
B179TMJ
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
customized bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |