Duns Number:053824652
Device Description: The BNS-40 is a miniaturized version of the Myomonitor designed to allow the patient to sa The BNS-40 is a miniaturized version of the Myomonitor designed to allow the patient to safely apply electrical stimulation while at home to relax tense muscles.
Catalog Number
4500
Brand Name
BNS-40 Home Treatment Unit
Version/Model Number
BNS-40
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
NUW
Product Code Name
Stimulator, Muscle, Powered, Dental
Public Device Record Key
c75c8da0-9504-4c08-8d33-e326d345ce6c
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
August 18, 2016
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 |
|---|---|---|
| 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 |