Duns Number:753358829
Device Description: The PeriCoach is a perineometer designed to treat stress, mild-moderate urge and mixed uri The PeriCoach is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology. The PeriCoach® device consists of a rigid probe covered in a silicone sheath that is temporarily inserted into the vagina. Sensors located under the sheath measure the strength of contraction of the user’s pelvic floor muscles. This information is then transmitted wirelessly to a smartphone application in order to provide real-time feedback to the user. It is a single patient, reusable device.
Catalog Number
NA
Brand Name
PeriCoach®
Version/Model Number
v3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
April 11, 2032
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
-
Product Code
HIR
Product Code Name
Perineometer
Public Device Record Key
eabe6dc9-7c83-4f50-b398-7e4df8b8005b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 10, 2017
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. | 1 |