Duns Number:362997926
Device Description: VisionHub with FlexVision Inclinometers, DynaVision Dynamic sEMG and ScanVision Static sEM VisionHub with FlexVision Inclinometers, DynaVision Dynamic sEMG and ScanVision Static sEMG Scanner
Catalog Number
D2-D5-D6-D7L
Brand Name
SERIES-5 MyoVision Full System
Version/Model Number
D2-D5-D6-D7L
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K123399
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
852fe694-b496-4b7d-9a70-28660f4b4548
Public Version Date
March 08, 2021
Public Version Number
1
DI Record Publish Date
February 28, 2021
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 | 43 |