Duns Number:369960000
Device Description: FemiScan device is for monitoring and recording muscle activity of the pelvic floor muscle FemiScan device is for monitoring and recording muscle activity of the pelvic floor muscles by using EMG-signals.
Catalog Number
-
Brand Name
FemiScan
Version/Model Number
HTCS-2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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
K993411
Product Code
HIR
Product Code Name
Perineometer
Public Device Record Key
f91f60bc-7a24-4949-89b2-d61d9f32f87f
Public Version Date
December 31, 2021
Public Version Number
6
DI Record Publish Date
September 22, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |