Duns Number:094651270
Device Description: Pelvic Floor Execiser System, Extended Vaginal Exerciser, For use with Liberty Stimulator Pelvic Floor Execiser System, Extended Vaginal Exerciser, For use with Liberty Stimulator PFS-200 only
Catalog Number
PFS-042
Brand Name
LIBERTY
Version/Model Number
Vaginal Exerciser with Handle
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"
Yes
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
03d19fad-81f4-4ea1-81a8-8cdfdd7441e5
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 |