Duns Number:569403736
Device Description: The Sure + is intended to provide electrical stimulation and neuromuscular re-education fo The Sure + is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women and to maintain urinary continence in women.The Sure + is intended for OTC use.
Catalog Number
K-SURE+USA
Brand Name
Tenscare
Version/Model Number
Sure+
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K191312
Product Code
KPI
Product Code Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Public Device Record Key
a3c0c88a-6dbe-4ea7-8857-a6e453e2cccb
Public Version Date
December 06, 2019
Public Version Number
1
DI Record Publish Date
November 28, 2019
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. | 7 |