Duns Number:094651270
Device Description: Pelvic Floor Execiser System, Stimulator Unit, For use with Liberty execiser probes only, Pelvic Floor Execiser System, Stimulator Unit, For use with Liberty execiser probes only, Includes Carrying Case, Batteries, and Instructional DVD
Catalog Number
PFS-200
Brand Name
LIBERTY
Version/Model Number
Stimulator
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
K960496
Product Code
KPI
Product Code Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Public Device Record Key
d303ed12-a9c1-47bf-ab50-21b5fdad8807
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 274 |