Duns Number:809608719
Device Description: NTrainer System
Catalog Number
A00002
Brand Name
NTrainer
Version/Model Number
A00002
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
K071866
Product Code
HCC
Product Code Name
Device, biofeedback
Public Device Record Key
92a9eabd-13b1-46e0-921d-f69e4dfd45fc
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 17, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |